Artificial stomach

ABSTRACT

A biocompatible implant for a method of treating a reflux disease in a patient by preventing the cardia sphincter from sliding through the patient&#39;s diaphragm hiatus opening into the patient&#39;s thorax, so as to maintain a pressure support from the patient&#39;s abdomen that supports the patient&#39;s cardia sphincter. The biocompatible implant has a rigid shape, a circumference of at least 15 mm and is configured to be introduced into the patient&#39;s abdomen through a trocar, be fully invaginatable in the patient&#39;s fundus wall, and function as an implantable movement restricting device preventing the cardia sphincter from sliding through the patient&#39;s diaphragm, when implanted.

This application is a continuation of U.S. application Ser. No.14/065,079, filed Oct. 28, 2013, which is a continuation of U.S.application Ser. No. 12/864,982, filed Jul. 28, 2010, which is the U.S.national phase of International Application No. PCT/SE2009/00058, filed29 Jan. 2009, which designated the U.S. and claims priority to SwedishApplication No. 0802138-8, filed 10 Oct. 2008, and claims the benefit ofU.S. Provisional Application No. 61/006,719, filed on 29 Jan. 2008, theentire contents of each of which are hereby incorporated by reference inthis application.

TECHNICAL FIELD

The present invention relates to an apparatus for treatingGastroesophageal Reflux Disease (GERD).

BACKGROUND

Gastroesophageal Reflux Disease (GERD), or acid reflux disease, is achronic condition resulting in mucosal damage in the oesophagus producedby the recurring occurrence of acid reflux in the oesophagus. This iscommonly due to transient or permanent changes in the barrier betweenthe oesophagus and the stomach. This can be due to incompetence of thelower esophageal sphincter (LES), transient LES relaxation, impairedexpulsion of gastric reflux from the esophagus, or a hiatal hernia.

Gastroesophageal Reflux Disease can be treated in a number of differentways. Treatments include, but are not limited to, both medical andsurgical treatments. A standard surgical treatment, which sometimes ispreferred over longtime use of medication, is Nissen fundoplicationsurgery, in which the upper curve of the stomach (the fundus) is wrappedaround the LES to strengthen the sphincter and prevent acid reflux andto repair a hiatal hernia. The procedure is often done laparoscopically.

Another surgical treatment which has been used is the Anglechikprosthesis, in which a device formed like a horseshoe is placed aroundthe oesophagus above the cardia. The intended effect is to prevent thecardia from slipping up into the thorax cavity. However, this device hasa number of complications, including migrating through and damaging theoesophagus.

From experience with implantation of medical devices, it is known thatsutures between an implanted device and human tissue will not hold overthe long term. For long term implantation of a device, there are twopossibilities to keep the device in place. A first solution has been tosuture human tissue to human tissue, to thereby keep the device inplace. A second approach has been to provide sutures holding a device inplace in the short term and to allow in-growth of human tissue into thedevice for holding the device in place over the long term.

A problem with providing an implantable device associated with theoesophagus is that the outer surface of the oesophagus is only comprisedof oesophagus muscle tissue, which is very easy to damage or migratethrough. This is probably one reason why the Anglechik prosthesisdescribed above has resulted in many complications, such as migration.

The stomach, on the other hand, has a serosa on its outside, therebyproviding a much stronger membrane for suturing. Thus, suturing a devicedirectly to the stomach wall provides a better result than suturing animplanted device to the oesophagus.

Today, there exists a need for a long term treatment of GERD that ismore effective than prior treatments and which does not result in anysevere complications.

SUMMARY OF THE INVENTION

It is an object of the present invention to overcome, or at leastreduce, some of the problems associated with existing surgicaltreatments of Gastroesophageal Reflux Disease (GERD).

It is another object of the present invention to provide an apparatusfor treating gastroesophageal reflux disease.

These objects and others are obtained by apparatus described in theappended claims. Thus, by providing an apparatus for the treatment ofacid reflux disease including an implantable movement restriction devicehaving an outer surface that includes a biocompatible material, whereinthe movement restriction device is adapted to rest with at least a partof its outer surface against the patient's stomach fundus wall, in aposition between the patient's diaphragm and the fundus wall, such thatmovement of the cardiac notch of the patient's stomach towards thepatient's diaphragm is restricted, an apparatus for treatingGastroesophageal Reflux Disease is obtained.

The movement restriction device has a size of at least 125 mm³ and acircumference of at least 15 mm and restricts movement of the cardiacnotch of the patient's stomach towards the patient's diaphragm therebypreventing the cardia from sliding through the patient's diaphragmopening into the patient's thorax, maintaining the supporting pressureagainst the patient's cardia sphincter muscle exerted from the patient'sabdomen. Fixation device are adapted to secure the movement restrictiondevice in said position.

By adapting the outer surface of the implanted movement restrictiondevice to rest against the wall of the fundus, there is a minimal riskof complications, such as migration of damage to tissue, because thefundus is less fragile than the oesophagus.

In a first embodiment of the invention, the fixation device comprisessutures or staples that attach together portions of the fundus stomachwall that enclose the movement restriction device to secure the movementrestriction device in said position. I.e., the movement restrictiondevice is at least partly placed in an invaginated space. Thus, byaffixing the implantable movement restriction device indirectly in thismanner, no suturing between the movement restriction device and tissueis required, which, in turn, further reduces the risk for complications.Keeping the movement restriction device in place in this manner hasresulted in an elastic suspension with improved long term properties.

The fixation device, such as sutures or staplers, may attach togetherportions of the fundus stomach wall so at to substantially or completelyinvaginate the movement restriction device from either inside or outsideof the patient's stomach wall. Where the movement restriction device isplaced on the outside of the patient's stomach wall, the movementrestriction device is invaginated by the fundus stomach wall such thatthe stomach cavity is substantially reduced, by a volume substantiallyexceeding the volume of the movement restriction device.

In a second embodiment of the invention, the fixation device comprisesan implantable first fixation device that attach the movementrestriction device in said position to the fundus wall, a secondfixation device that secures, indirectly or directly, the movementrestriction device to the oesophagus close to the patient's angle ofHis, and a third fixation device that secures, indirectly or directly,the movement restriction device to the patient's diaphragm muscle orassociated muscles. Any of the first, second and third fixation devicesmay be comprised of a plurality of sutures or staples. The firstfixation device may comprise a tissue growth promoting structure forlong term attachment of the movement restriction device to the stomachwall. The tissue growth promoting structure may be sutured to thestomach wall with a relatively large contact surface towards thestomach. The relatively large surface of the structure, such as a net,will allow for in-growth of human tissue for holding the movementrestriction device in place over the long term. The tissue growthpromoting structure may comprise sutures or staples that attach the netlike structure to the fundus stomach wall.

In addition to invaginating the movement restriction device inaccordance with the first embodiment of the invention, the secondfixation device can be used to secure, indirectly or directly, themovement restriction device to the oesophagus close to the patient'sangle of His, and the third fixation device may be used to secure,indirectly or directly, the movement restriction device to the patient'sdiaphragm muscle or associated muscles.

At least a part of the movement restriction device may be made of amaterial which is destructible or not destructible by stomach acid.

The movement restriction device may be inflatable and adapted to beinflated with a gel or fluid. A fluid or gel receiving member forreceiving fluid to inflate the movement restriction device may beprovided.

The movement restriction device may include a homogenous material andmay be a solid body.

The movement restriction device may include an enclosure wall defining achamber.

The movement restriction device may have a rigid, elastic or flexibleouter wall. Where the outer wall is rigid, it is rigid enough tomaintain non-deformed when subject to forces created by stomachmovements. Where the movement restriction device is invaginated, inaccordance with the first embodiment described above, the movementrestriction device preferably comprises a body adapted to be at leastpartly invaginated by the patient's stomach fundus wall and having anouter surface that includes a biocompatible material. A substantial partof the outer surface of the body is adapted to rest against the stomachwall in said position between the patient's diaphragm and the portion ofthe lower part of the invaginated stomach fundus wall. Suitably, thebody is made of a material softer than 25 or 15 shure.

In accordance with a first general design of the body, the body has amaximum circumference as seen in a plane perpendicular to an axisthrough the body. The circumferences of the body as seen in other planesperpendicular to said axis are equal to the maximum circumference ordecrease as seen along said axis in the direction from the maximumcircumference. For example, the body may be substantially egg shaped,spherically shaped, or substantially shaped like an egg with an indentedmiddle section or like a bent egg.

In accordance with a second general design of the body, thecircumference of the body as seen in a plane perpendicular to an axisthrough the body increases and decreases at least two times as the planeis displaced along said axis, or decreases and increases at least onetime as the plane is displaced along said axis. For example, the bodymay be substantially shaped like a kidney.

Preferably, the body is dimensioned with a size larger than theintestinal outlet from the stomach. The body may have a smallest outerdiameter of 30 or 40 mm or larger and may have a smallest outercircumference of 150, 110, 90, 70, 50 or 30 mm.

Suitably, the body has rounded contours without too sharp edges thatwould be damaging to the patient's stomach wall, and has a generallysmooth outer surface for resting against the fundus wall.

The body is implantable either inside or outside of the patient'sstomach and is adapted to be attached to the patient's stomach wall bysurgery. The body may be changeable to assume a slender form having asmaller diameter than that of a trocar for laparoscopic use, whereby thebody when changed to said slender form can be pushed or pulled throughthe trocar. The body may include a flexible outer wall defining achamber filled with a fluid, such as a gel, allowing the body to passthrough such a trocar. Alternatively, the body may include an elasticcompressible material, allowing the body to pass through a trocar.

The body may be hollow and include at least two separate pieces adaptedto be inserted into the hollow body, and further adapted to be puttogether to one unitary piece inside the body, thereby allowing the bodyto pass through a trocar for laparoscopic use. Alternatively, the bodymay include an outer wall and a hollow compressed inner part, for beingfilled with a fluid or gel after insertion into the patient's body.

The body may include a chamber with an injection port, wherein thechamber of the body is filled with a fluid through the injection port.

The body may include at least one holding device adapted to be used forpushing or pulling the body through a trocar for laparoscopic use. Theholding device is adapted to hold a prolongation of the body that isadapted to be held by a surgical instrument. More specifically, theholding device is adapted to hold a thread or band inserted through theholding device. Where the body comprises an outer wall the holdingdevice is at least partly placed inside the outer wall of the body.

In an advantageous embodiment, the body is adjustable in size andinvaginated in the patient's fundus stomach wall. As a result, the bodystretches the patient's stomach fundus wall when the size thereof isincreased, thereby creating satiety in a patient also suffering fromobesity. At least two implantable adjustable stretching devices may beprovided to stretch different parts of the patient's stomach wall, tothereby treat obesity by efficiently affecting the patient's appetite.The two stretching devices are suitably regulated from outside of thepatient's body, whereby a first of the stretching devices is regulatedat a first time to stretch a first part of the patient's stomach walland a second of the stretching devices is regulated at a second time tostretch a second part of the patient's stomach wall.

The stretching device may be hydraulically regulated. In this case, asubcutaneously implantable hydraulic reservoir connected to thehydraulic regulated stretching device may be provided, whereby thehydraulic regulated stretching device is non-invasively regulated bymanually pressing the hydraulic reservoir. Further, the movementrestriction device suitably includes an inflatable body, and a pump anda chamber in fluid contact with the body are provided, wherein the pumpregulates the hydraulic reservoir by pumping fluid or air from the bodyto the chamber.

The apparatus may include an implantable stimulation device that sendsout stimulation pulses to the cardia muscle to stimulate the cardiamuscle and thereby further close the cardia to additionally preventreflux disease. The stimulation device is comprised of at least oneconductor and at least one electrode that receives the stimulationpulses and applies them to the cardia muscle to thereby stimulate thecardia muscle. The at least one electrode may also be kept in place bythe stomach-oesophagal sutures or invagination in the stomach wall. Thestimulation pulses may be sent as a train of pulses, wherein the pulsetrain is repeated with a time break in between, the break extending thebreak between each pulse in the pulse train. The stimulation device mayinclude an electronic circuit and an energy source preferably adapted toincorporate the electronic circuit and energy source. In one embodiment,the stimulation of the cardia with the stimulation device is made withenergy pulses to increase the sphincter tonus so that the cardiacompletely closes and a control device for controlling the stimulationdevice is operable by the patient to set the stimulation device intooperation, in which operational state the stimulation devicecontinuously alternates at a time when the patient does not swallowbetween an operation mode in which the cardia sphincter is stimulatedwith said energy pulses and a rest mode in which the cardia is notstimulated.

The stimulation device preferably comprises at least one sensor forsensing a physical parameter of the patient or a functional parameter ofthe movement restriction device and an internal control unit forcontrolling the stimulation device.

Normally, the internal control unit controls the stimulation device inresponse to information from the sensor.

A sensor sensing a contraction wave of the oesophagus, or any otherparameter correlated to food intake, sends the information to theinternal control unit and the internal control unit then ceases thestimulation in response to such information from the sensor.

The stimulation device may, at any time, be controlled by the patient.

The present invention further relates to abdominal surgical methods oftreating a reflux disease.

According to a first method a reflux disease in a patient is treated byimplanting a movement restriction device that, when implanted in apatient, restricts the movement of the stomach notch in relation to thediaphragm muscle preventing the cardia to slide up through the diaphragmhiatus opening. The method comprises the steps of inserting a needle ora tube like instrument into the abdomen of the patient's body; using theneedle or tube like instrument to fill the patient's abdomen with gas;placing at least two laparoscopic trocars in the patient's body;inserting a camera through one of the laparoscopic trocars into thepatient's abdomen, inserting at least one dissecting tool through one ofsaid at least two laparoscopic trocars; dissecting an area of thestomach; introducing the device into the abdominal cavity; placing thedevice on the outside of the stomach fundus wall; and creating a pouchin the stomach fundus wall for the device; and in-vaginating the devicein the pouch by providing sutures or staples to the stomach fundus wall,thereby preventing the cardia from sliding through the patient'sdiaphragm opening into the patient's thorax, so as to maintain thepressure support from the patient's abdomen that supports the patient'scardia sphincter muscle.

A second abdominal method of treating a reflux disease for the samepurpose uses the initial steps as the first method comprises creating ahole in the stomach fundus wall; introducing a movement restrictiondevice into the abdominal cavity; introducing the device through thehole and into the stomach; placing the device on the inside of thestomach fundus wall; creating a pouch on the outside of the stomachcavity for the device placed on the inside of the stomach fundus wall,and in-vaginating the device in the pouch by providing sutures orstaples to the stomach fundus wall, preventing the cardia from slidingthrough the patient's diaphragm opening into the patient's thorax, so asto maintain the supporting pressure from the patient's abdomen thatsupports the patient's cardia sphincter muscle.

A third abdominal method of treating a reflux disease in a patientincludes implanting a movement restriction device for the same purposeas previously disclosed methods and comprises the steps of surgicallyincising an opening in the patient's abdominal wall; dissecting an areaof the patient's stomach; introducing the movement restriction devicethrough the abdominal incision; and attaching the device to the stomachfundus wall, thereby preventing the cardia from sliding through thepatient's diaphragm opening into the patient's thorax, so as to maintainthe supporting pressure from the patient's abdomen that supports thepatient's cardia sphincter muscle. According to first alternative, themethod includes placing the device on the outside of the stomach funduswall; creating a pouch in the stomach fundus wall for the device; andin-vaginating the device in the pouch by providing sutures or staples tothe stomach fundus wall, thereby preventing the cardia from slidingthrough the patient's diaphragm opening into the patient's thorax, so asto maintain the supporting pressure from the patient's abdomen thatsupports the patient's cardia sphincter muscle. According to a secondalternative, the method includes creating a hole in the stomach funduswall; introducing the movement restriction device through the hole andinto the stomach; placing the device on the inside of the stomach funduswall; creating a pouch on the stomach fundus wall for the device, andin-vaginating the device in the pouch by providing sutures or staples tothe stomach fundus wall, preventing the cardia from sliding through thepatient's diaphragm opening into the patient's thorax, so as to maintainthe supporting pressure from the patient's abdomen that supports thepatient's cardia sphincter muscle.

The methods further comprise affixing the device to the stomach funduswall by providing sutures or staples and/or affixing the stomach funduswall to the lower part of the patient's esophagus by providing suturesor staples; and/or affixing the stomach fundus wall to the patient'sdiaphragm muscle or associated muscles. The methods can further comprisethe provision of an apparatus for regulating the reflux treatment devicefrom the outside of the patient's body; and operating said apparatus toregulate the reflux treatment device. The regulation of the refluxtreatment device can include changing the volume of the filling bodywhen implanted. For this purpose, the methods can include the provisionof an injection type syringe comprising a fluid for injection into animplanted filling body; and injecting volume of fluid into filling body.Preferably, the methods comprise enclosing the device in the pouch. Inone embodiment, the method admits the pouch being at least partly open,whereby the pouch can exhibit only one opening, or the pouch can exhibittwo openings and to extend non-circumferentially around the stomach. Itis generally preferable that the volume of the pouch is more than 15millilitres

A further laparoscopic abdominal method of treating a reflux diseasecomprises inserting a needle or a tube like instrument into the abdomenof the patient's body; using the needle or tube like instrument to fillthe patient's abdomen with gas; placing at least two laparoscopictrocars in the patient's body; inserting a camera through one of thelaparoscopic trocars into the patient's abdomen; inserting at least onedissecting tool through one of said at least two laparoscopic trocars;dissecting an area of the stomach; creating a pouch from the stomachfundus wall for the device; closing the pouch by providing sutures andstaples; introducing a injecting member comprising an injectable fillingmaterial; and injecting the filling material into the pouch, therebycreating a filling body that, fills a volume in the patient's abdomenthat is close to and above the patient's cardia when the patient is in astanding position in order to prevent the cardia from sliding throughthe patient's diaphragm opening into the patient's thorax, so as tomaintain pressure in the patient's abdomen supporting the patient'scardia sphincter muscle.

A further surgical abdominal method of treating a reflux diseasecomprises cutting an opening in the skin to enter the patients abdomendissecting an area of the stomach; creating a pouch from the stomachfundus wall for the device; closing the pouch by providing sutures andstaples; introducing a injecting member comprising an injectable fillingmaterial; and injecting the filling material into the pouch, therebycreating a filling body that, fills a volume in the patient's abdomenthat is close to and above the patient's cardia when the patient is in astanding position in order to prevent the cardia from sliding throughthe patient's diaphragm opening into the patient's thorax, so as tomaintain pressure in the patient's abdomen supporting the patient'scardia sphincter muscle.

The recited further methods can include creating the pouch on theoutside of the stomach fundus wall, with the filling body placed againstthe inside of the stomach fundus wall, or alternatively, the methodsinclude creating a hole in the stomach fundus wall and the pouch iscreated on the inside of the stomach fundus wall, with the filling bodyplaced against the outside of the stomach fundus wall. The recitedfurther methods preferably also include affixing the stomach fundus wallto the lower part of the patient's esophagus by providing sutures orstaples and/or affixing the stomach fundus wall to the patient'sdiaphragm muscle or associated muscles. It is also generally preferablethat the volume of the pouch is more than 15 millilitres. The fillingmaterial is preferably capable of undergoing a curing process from fluidmaterial to a semi-solid or solid material. Such a curing process ispreferably triggered by an increase in temperature from ambienttemperature to body temperature. A suitable such material, well-known topersons skilled in the art, is a thermocurable polysiloxane which (inthe presence of a crosslinker and a catalyst) can undergo a crosslinkingreaction under the influence of heat.

A still further laparoscopic abdominal method of treating a refluxdisease in a patient by implanting a movement restriction device that,when implanted in a patient, restricts the movement of the stomach notchin relation to the diaphragm muscle preventing the cardia to slide upthrough the diaphragm hiatus opening, comprises the steps of inserting aneedle or a tube like instrument into the abdomen of the patient's body;using the needle or tube like instrument to fill the patient's abdomenwith gas; placing at least two laparoscopic trocars in the patient'sbody; inserting a camera through one of the laparoscopic trocars intothe patient's abdomen; inserting at least one dissecting tool throughone of said at least two laparoscopic trocars; dissecting an area of thestomach; creating a hole in the stomach fundus wall; introducing amovement restriction device into the abdominal cavity, introducing thedevice through the hole and into the stomach; placing the device on theoutside of the stomach fundus wall; fixating the device placed on theoutside of the stomach fundus wall, and preventing the cardia fromsliding through the patient's diaphragm opening into the patient'sthorax, so as to maintain the supporting pressure from the patient'sabdomen that supports the patient's cardia sphincter muscle. The methodcan further comprise the step of affixing the device to the stomachfundus wall by providing sutures or staples.

The present invention also relates to a laparoscopic instrument forproviding a movement restriction device to be invaginated in the stomachfundus wall of a human patient to treat reflux disease, suitable for usewith any of the mentioned laparoscopic methods. The instrument generallycomprises an elongated member having a proximal end and a distal end,the elongated member having a diameter less than that of a laparoscopictrocar to be introduced into the patients abdomen during a laparoscopicoperation; a stomach pushing device for pushing the stomach fundus wallto create a tube like shaped portion of the stomach fundus wallprotruding into the normal stomach cavity, said pushing devicecomprising the movement restriction device to be invaginated by thestomach fundus wall in the tube like shaped portion thereof. The pushingdevice comprises a vacuum sucking device to suck the stomach fundus toassist the instrument in forming the tube like shaped portion of thestomach fundus wall together with the pushing device. The vacuum suckingdevice comprises a vacuum passageway leading from the proximal to thedistal end of the instrument and at the end portion of the instrument,which includes the pushing device. The vacuum passageway is divided upin multiple small openings adapted to suck the stomach wall portion tobecome adherent to the pushing device to further form the tube likestomach wall portion. The instrument further comprises an insertiondevice adapted to introduce the movement restriction device into thetube like shaped stomach portion. The instrument can further comprise atleast one clamping device for holding the opening of the tube likeportion substantially closed by clamping together stomach to stomach insaid opening, wherein the instrument is adapted to place the at leastone clamping device at the opening in such a way that it allows latersuturing of the opening. The instrument can further comprise aninflation device for inflating the movement restriction device before orafter the suturing. The instrument can further comprise a suturingdevice adapted to suture the opening of the tube like portion withstomach to stomach sutures for creating at least partly a closed spaceenclosing the movement restriction device, wherein the instrument isadapted to be withdrawn leaving the movement restriction device at leastpartly invaginated in the stomach fundus wall. The suturing device cancomprise a first and second suture positioning member provided on theelongated member to be located in the stomach at the distal end thereof.The instrument further comprises an operation device adapted to adjustthe first and second suturing member in a position in which the firstand second suture positioning members are in front of each other withthe stomach wall on both sides of the open end of the cup like portion,and adapted to suture the open end of the cup like portion of the funduswall with a row of stomach to stomach sutures. The suturing devicepreferably comprises an operable reloadable multi-suturing device, whichis reloadable with sutures from outside of the patient's body and whichis adapted to suture the open end of the cup like portion of the funduswall with said row of stomach to stomach sutures, wherein the row ofsutures comprises two or more sutures or staples to be suturedsimultaneously. The suturing device can also comprise multiple suturesfor suturing two or more sutures simultaneously.

The present invention also relate an intraluminar method of treating areflux disease in a patient by implanting a device comprising animplantable movement restriction device that, when implanted in apatient, restricts the movement of the stomach notch in relation to thediaphragm muscle preventing the cardia to slide up through the diaphragmhiatus opening. The method comprises the steps of introducing agastroscope in the esophagus and into the stomach of the patient;introducing an instrument in the esophagus and into the stomach of thepatient, said instrument being integrated in said gastroscope orseparate from the same; providing, by means of said of instrument, apouch from the stomach fundus wall for accommodating the device andinvaginating the device in the pouch with sutures or stables to thestomach fundus wall, thereby preventing the cardia from sliding throughthe patient's diaphragm opening into the patient's thorax, so as tomaintain the supporting pressure against the patient's cardia sphinctermuscle exerted from the patient's abdomen. In a first alternative, themethod comprises the steps of introducing the device into the stomach bymeans of the instrument; placing the device on the inside of the stomachfundus wall, using said instrument; creating, by means of saidinstrument, a pouch in a portion of the stomach fundus wall on theoutside of the stomach cavity, the device placed resting against theinside of the stomach fundus wall; and invaginating the device in thepouch by with sutures or stables to the stomach fundus wall. In a secondalternative, the method comprises the steps of creating, by means ofsaid instrument, a pouch of a portion of the stomach fundus wall;introducing the device by means of the instrument into the pouch; andinvaginating the device with sutures or stables to the stomach funduswall. According to this alternative, the method comprises inflating thedevice to its filling volume, preferably by injecting a filling fluidinto the device so it obtains its filling volume. The filling fluid canthereby be a curable fluid of the characteristics earlier describes,such as the aforedescribed thermocurable polysiloxanes. In a thirdalternative, the method comprises the steps of creating a hole in thestomach fundus wall; introducing the device into the stomach by means ofthe instrument; moving the device through the hole and placing it on theoutside of the stomach fundus wall; creating, by means of saidinstrument, a pouch of a portion of the stomach fundus wall on theinside of the stomach cavity, with the device placed against the outsideof the stomach fundus wall; invaginating the device in the pouch withsutures or stables to the stomach fundus wall; and sealing the hole withsutures or staples. In a fourth alternative, the method comprises thesteps of creating a hole in the stomach fundus wall; creating, by meansof said instrument, a pouch of a portion of the stomach fundus wall onthe inside of the stomach cavity; introducing the device into thestomach by means of the instrument; moving the device through the holeand placing it on the outside of the stomach fundus wall; introducingthe device by means of the instrument into the pouch; invaginating thedevice with sutures or stables to the stomach fundus wall; and sealingthe hole with sutures or staples. Also this method can compriseinflating the device to its filling volume, preferably by injecting afilling fluid into the device so it obtains its filling volume. Thefilling fluid can have all the previously described characteristics. Themethod also comprises affixing the device to the stomach fundus wall byproviding sutures or staples; and/or affixing the stomach fundus wall tothe lower part of the patient's oesophagus by providing sutures orstaples; and/or affixing the stomach fundus wall to the patient'sdiaphragm muscle or associated muscles. The method can also comprise theprovision of an apparatus for regulating the reflux treatment devicefrom the outside of the patient's body; and operating said apparatus toregulate the reflux treatment device. Regulation of the reflux treatmentdevice preferably includes changing the volume of the filling body whenimplanted. For this purpose, the method can comprise the provision of aninjection type syringe comprising a fluid for injection into animplanted filling body; and injecting volume of fluid into filling body.The filling fluid can be curable fluid of a nature as discussed inprevious sections. The pouch created by the method can enclose themovement restriction device, or it can be at least partially open, inone example it has only one opening, and according to another example itexhibits two openings and extends non-circumferentially around thestomach. Preferably, the volume of the pouch is more than 15millilitres. It is generally preferably in the method that thegastroscope and the instrument are integrated. The method can furtherinclude inflating the stomach with gas. In a special embodiment of themethod, the instrument generates vacuum when providing the pouch fromthe stomach fundus wall.

The invention also relates to a method of restoring the location of thecardia and the fundus in a patient suffering from a reflux diseasecomprising introducing an elongated instrument having at least oneflexible part into oesophagus of a patient; activating a holding deviceby the instrument, said activated holding device having largercrossectional area than said instrument; holding the distal esophagus orstomach with said holding device; moving and pushing the instrument in adistal direction so the cardia and the stomach wall, or part of fundus,incorrectly located above diaphragm, or its associated muscles, slideback in a position below the diaphragm, or its associated muscles. In afirst alternative, the method comprises expanding the holding deviceradially above the cardia in the oesophagus and using the device to pushthe cardia and the stomach wall or part of fundus below the diaphragm orits associated muscles. In a second alternative, the method comprisesreleasing a balloon member at the proximal end of the instrument in thelower part of the stomach, and using the member to push the instrumentagainst a lower wall part of the stomach so the cardia and the fundus orpart of fundus slide below the diaphragm or its associated muscles. In athird alternative, the method comprises locating the distal end of theinstrument at the level of the diaphragm or its associated muscles;expanding the member in radial direction; attaching the member to thestomach wall; and pushing the instrument in a distal direction so thecardia and the stomach wall or, part of fundus, slide below thediaphragm or its associated muscles. The method according to all recitedalternatives can comprise the employment of an affixing member as partof the holding device in the distal part of the instrument capableproviding sutures or stables or other invasive mechanical members foraffixing the esophagus and stomach wall to the instrument, preferably,the method comprises the employment of a suturing member in the distalpart of the instrument capable providing sutures or stables for suturingthe stomach fundus wall to the lower part of the esophagus above saidcardia,

The invention is also directed to a surgical gastroscopic instrument fortreating a patient suffering from hiatal hernia, wherein a portion ofthe patient's stomach passes through the hiatus of the diaphragm musclewith the patient's cardia placed above the diaphragm muscle in thethorax. The instrument comprises: (i) an elongated member having aproximal end and a distal end, said elongated member having a diameterless than that of the patient's esophagus and being flexible, therebyallowing introducing the flexible elongated member with its distal endfirst from the throat into the esophagus; (ii) a holding device securedto the elongated member and operable between an activated state, inwhich it is adapted to engage and hold the patient's esophagus orstomach, and an inactivated state, in which it is adapted to be releasedfrom the esophagus or stomach; (iii) an operation device for operatingthe holding device to shift between said activated and inactivatedstates from outside the patient's body; and (iv) a handle connected tothe elongated member at the proximal end thereof to be held manually formoving the elongated member distally, wherein the holding device, whenoperated by the operation device in its activated state, is adapted toengage and hold the esophagus or stomach strong enough to allow theelongated member, when manually moved, to move and reintroduce thecardia back in the distal direction to a position below the diaphragmmuscle. The operable holding device of the instrument is preferablyadapted to radially expand relative to the elongated member from saidinactivated state to said activated state, such that said holdingdevice, when radially expanded, engages and holds the stomach oresophagus by force and friction. Alternatively, the operable holdingdevice comprises at least one introducing member adapted to invasivelyintroduce into the wall of the stomach or esophagus to secure theholding device on the esophagus or the stomach, when the holding deviceis in its activated state. In both alternatives, the operable holdingdevice is adapted to engage and hold the esophagus proximal to thecardia or at the cardia, or to engage and hold the stomach at a positionin the hiatus or distal thereto, when the cardia is above the diaphragmmuscle. According to another alternative, the elongated member of theinstrument comprises a first suture positioning member, which issituated in the esophagus when the holding device is in its activatedstate holding the esophagus or stomach, and a second suture positioningmember at the distal end of the elongated member. The operation deviceof the instrument is adapted to bend the flexible elongated memberaround the stomach notch into a position in which the first suturepositioning member is above the cardia and the first and second suturepositioning members are in front of each other with the fundus wall andesophagus wall moved together by the first and second suture positioningmembers. The instrument further comprises a reloadable multi-suturingdevice for suturing together the patient's esophagus proximal to thecardia with the fundus stomach wall by a row of sutures, where thefundus wall and esophagus wall are moved together by the first andsecond suture positioning members, said row of sutures comprising two ormore sutures to be sutured simultaneously by the multi-suturing device.

The invention further comprises another embodiment of a surgicalgastroscopic instrument for treating a human patient suffering fromhiatal hernia, This instrument comprises: (i) an elongated member havinga proximal end and a distal end, said elongated member having a diameterless than that of the patient's esophagus and being flexible, therebyallowing introducing the flexible elongated member with its distal endfirst from the patient's throat into the esophagus; (ii) a first suturepositioning member provided on the elongated member such that it issituated in the esophagus proximal to the cardia when the elongatedmember has been introduced in the esophagus with the distal end of theelongated member situated in the stomach; (iii) a second suturepositioning member provided on the elongated member at the distal endthereof, (iv) an operation device adapted to bend the flexible elongatedmember around the stomach notch into a position in which the first andsecond suture positioning members are in front of each other with thefundus wall and esophagus wall moved together by the first and secondsuture positioning members; and (v) a re-loadable multi-suturing devicefor suturing together the patient's esophagus proximal to the cardiawith the fundus stomach wall by a row of sutures, where the fundus walland esophagus wall are moved together by the first and second suturepositioning members, the multi-suturing device being to reloadable withsutures from outside the body to apply further rows of sutures in frontor back of the first row of sutures, wherein said row of suturescomprises two or more sutures to be sutured simultaneously by themulti-suturing device. The instrument further comprises a holding devicesecured to the elongated member and operable between an activated state,in which it is adapted to engage and hold the patient's esophagus orstomach, and an inactivated state, in which it is adapted to be releasedfrom the esophagus or stomach. The holding device is operable by theoperation device to shift between said activated and inactivated statesfrom outside the patient's body, and a handle connected to the elongatedmember at the proximal end thereof to be held manually for moving theelongated member distally, wherein the holding device, when operated bythe operation device in said activated state, is adapted to engage andhold the esophagus or stomach strong enough to allow the elongatedmember, when manually moved, to move and reintroduce the cardia back inthe distal direction to a position below the diaphragm muscle. In onealternative, the operable holding device is adapted to radially expandrelative to the elongated member from said inactivated state to saidactivated state, such that the holding device, when radially expanded,engages and holds the stomach or esophagus by force and friction. Inanother alternative, the operable holding device comprises at least oneintroducing member adapted to invasively introduce into the wall of thestomach or esophagus to secure the holding device on the esophagus orthe stomach, when the holding device is in its activated state. In bothalternatives, the operable holding device is adapted to engage and holdthe esophagus proximal to the cardia or at the cardia, or to engage andhold the stomach at a position in the hiatus or distal thereto, when thecardia is above the diaphragm muscle.

The invention further comprises still another embodiment of a surgicalgastroscopic instrument for providing a movement restriction device tobe invaginated in the stomach fundus wall of a human patient to treatreflux disease. The instrument comprises (i) an elongated member havinga proximal end and a distal end, the elongated member having a diameterless than that of the patient's esophagus and being flexible, therebyallowing introduction of the flexible elongated member with its distalend first through the patient's throat, esophagus and into the stomachto the fundus wall; (ii) an operable stomach penetration device providedthe elongated member at the distal end thereof for penetrating thestomach fundus wall to create a hole in the stomach fundus wall, toallow introduction of the elongated member through the hole; (iii) anoperable special holding device provided on the elongated memberproximal to the penetration device, when penetrating said stomach wall,to hold the elongated member in a position in which the elongated memberextends through the stomach fundus wall and is prevented from movingthrough the hole in the proximal direction, wherein the special holdingdevice includes an expandable member expandable at least radiallysubstantially perpendicular to the elongated member to abut against thefundus wall on the outside thereof; and (iv) an insertion device forinserting the movement restriction device through the hole in thestomach fundus wall to the outside thereof to be invaginated in thefundus wall. The instrument can further comprise a forming deviceprovided on the elongated member proximal to the special holding deviceto abut against the fundus wall on the inside thereof. The formingdevice together with the special holding device is adapted to form thestomach fundus wall in a cup like shape, whereby the special holdingdevice is retractable relative to the forming device to pull the stomachwall against the forming device to form said cup like shaped portion ofthe stomach. The instrument can further comprise a suturing deviceadapted to suture the open end of the cup like portion of the funduswall with stomach to stomach sutures to create a space that is at leastin part enclosed by a portion of the fundus wall. The suturing devicepreferably comprises multiple sutures for suturing two or more suturessimultaneously. The suturing device is adapted to suture the open end ofthe cup like portion of the fundus wall before the movement restrictiondevice is inserted by the insertion device through the hole of thefundus wall. The instrument can further comprise an inflation device forinflating the movement restriction device after being introduced by theinsertion device through the hole of the fundus wall, or for inflatingthe movement restriction device after being introduced by the movementrestriction device introduced through the hole of the fundus wall. Thesuturing device can comprise an operable reloadable multi-suturingdevice, which is reloadable with sutures from outside the patient's bodyand which is adapted to suture the open end of the cup like portion ofthe fundus wall with a row of stomach to stomach sutures, wherein therow of sutures comprises two or more sutures or staples to be suturedsimultaneously. In another alternative, the instrument comprises aninflatable movement restriction device, the penetration device comprisesa wire adapted to be introduced through the hole in the stomach funduswall and to be advanced at least up to the abdominal wall or be passedtherethrough. The wire serves as a guide for a hydraulic tube, which isconnected to the inflatable movement restriction device and which isconnectable to an injection port to be placed subcutaneously for fillingthe inflatable movement restriction device with a fluid and adjustingthe amount thereof, when the movement restriction device has beeninserted by the insertion device through the hole of the fundus wall.

The invention further comprises still yet another embodiment of asurgical gastroscopic instrument for providing an inflatable movementrestriction device to be invaginated in the stomach fundus wall of ahuman patient to treat reflux disease. The instrument comprises: (i) anelongated member having a proximal end and a distal end, the elongatedmember having a diameter less than that of the patient's esophagus andbeing flexible, thereby allowing introduction of the flexible elongatedmember with its distal end first through the patient's throat, esophagusand into the stomach to the fundus wall; and (ii) an operable stomachpenetration device provided on the elongated member at the distal enthereof for penetrating the stomach fundus wall to create a hole in thestomach fundus wall, to allow introduction of the elongated memberthrough the hole, wherein the penetration device includes a wire to beintroduced through the hole in the stomach fundus wall and to beadvanced at least up to the abdominal wall or be passed therethrough,said wire serving as a guide for a hydraulic tube, which is connected tothe inflatable movement restriction device and which is connectable toan injection port to be placed subcutaneously for filling the inflatablemovement restriction device with a fluid and adjusting the amountthereof, and wherein at least one of the wire and tube can be pulled tomove the movement restriction device inflated with fluid towards thefundus stomach wall to be placed on the inside of the stomach funduswall where the movement restriction device is to be invaginated in thefundus wall. Preferably, at least one of the wire and tube when pulledto move the inflated movement restriction device towards the fundusstomach wall allow a portion of the stomach fundus wall to move to forma cup like shaped portion of the stomach protruding out from the normalstomach cavity. The instrument can further comprise an operable formingdevice having a cup like shape for forming the cup like shaped portionof the stomach. The instrument can further comprise a suturing deviceadapted to suture the open end of the cup like portion of the funduswall with stomach to stomach sutures to create a space that is at leastin part enclosed by a portion of the fundus wall. The suturing devicecan comprises multiple sutures for suturing two or more suturessimultaneously. The suturing device can be adapted to suture the openend of the cup like portion of the fundus wall before the movementrestriction device is inserted through the hole of the fundus wall. Themovement restriction device, preferably is inflatable, furthercomprising an inflation device for inflating the movement restrictiondevice after being introduced through the hole of the fundus wall. Theinstrument can further comprise a first and second suture positioningmember provided on the elongated member situated in the stomach at thedistal end thereof, and an operation device adapted to adjust the firstand second suturing member in a position in which the first and secondsuture positioning members are in front of each other with the stomachwall on both sides of the open end of the cup like portion, and adaptedto suture the open end of the cup like portion of the fundus wall with arow of stomach to stomach sutures. The suturing device can comprise anoperable re-loadable multi-suturing device, which is reloadable withsutures from outside the patient's body and which is adapted to suturethe open end of the cup like portion of the fundus wall with said row ofstomach to stomach sutures, wherein the row of sutures comprises two ormore sutures or staples to be sutured simultaneously. The inventionfurther comprises still yet another embodiment of a surgicalgastroscopic instrument providing a movement restriction device to beinvaginated in the stomach fundus wall of a human patient to treatreflux disease. The instrument comprising: (i) an elongated memberhaving a proximal end and a distal end, the elongated member having adiameter less than that of the patient's esophagus and being flexiblesuch that introduction of the flexible elongated member with its distalend first through the patient's throat, esophagus and into the stomachto the fundus wall is allowed; (ii) an operable stomach pushing devicefor pushing the stomach fundus wall to create a cup like shaped portionof the stomach fundus wall protruding out from the normal stomachcavity, said pushing device including the movement restriction device tobe invaginated by the stomach fundus wall in the cup like shaped portionthereof; and (iii) a suturing device adapted to suture the opening ofthe cup like shaped portion of the stomach fundus wall with stomach tostomach sutures to enclose at least in part the movement restrictiondevice. The instrument further can comprise a forming device provided onthe elongated member proximal to the pushing device to pull the funduswall on the inside thereof. The forming device together with the pushingdevice is adapted to form the stomach fundus wall in an optimal cup likeshape, wherein the pushing device is pushed to form said cup like shapedportion of the stomach. The instrument can further comprise first andsecond suture positioning member provided on the elongated membersituated in the stomach at the distal end thereof, and an operationdevice adapted to adjust the first and second suturing member in aposition in which said first and second suture positioning members arein front of each other with the stomach wall on both sides of the openend of the cup like portion, and adapted to suture the open end of thecup like portion of the fundus wall with a row of stomach to stomachsutures. The suturing device can comprise an operable re-loadablemulti-suturing device, which is reloadable with sutures from outside thepatient's body and which is adapted to suture the open end of the cuplike portion of the fundus wall with said row of stomach to stomachsutures, wherein the row of sutures comprises two or more sutures orstaples to be sutured simultaneously. The suturing device can alsocomprise multiple sutures for suturing two or more suturessimultaneously. The instrument can further comprise an inflating devicefor inflating the movement restriction device after the suturing. Theforming device can preferably comprise a vacuum sucking device to suckthe stomach fundus to help the instrument to form the cup like shapedportion of the stomach fundus wall together with the pushing device. Theembodied gastroscopic instruments as described in previous section cancomprise an optical device for examining the inside the esophagus or thestomach. For this purpose, the instruments can further compriseelectrical wires extending along the elongated member, and the opticaldevice comprises a camera placed distally on the elongated member andconnected to the wires, which lead out from the patient's body forexternal exposure of images from the camera. The instruments can furthercomprise a light source placed distally on the elongated member forilluminating the inside of the esophagus or stomach. The optical devicecan suitably comprise optical fibers placed along the elongated memberand leading out from the patient's body for external examination of theinside of the esophagus or stomach. The present invention furtherrelates to an apparatus for treating a reflux disease and obesity. Thisapparatus comprises a movement restriction device and the fixationdevices, adjustment device, wireless remote control function, wirelessenergy transmitter and further features as described earlier with anapparatus for treating a reflux disease. In addition the apparatus forcombined treatment of a reflux disease comprises at least one operablestretching device that, when implanted in the patient, stretches a partof the patient's stomach wall, to thereby treat obesity by affecting thepatient's appetite; and an operation device for operating the stretchingdevice when implanted to stretch the stomach wall portion such thatsatiety is created. The stretching device may be kept in contact withthe stomach wall by stomach-to-stomach sutures or staplers, in aposition in which the stretching device is capable of stretching thestomach wall. Specifically, the stretching device may be invaginated bythe stomach wall by means of stomach-to-stomach sutures or staplers. Thestretching device may be adapted to be placed in the stomach cavity. Tothis end, the stretching device may be adapted to be inserted into thestomach cavity via a gastroscope or intraluminar instrument, and beadapted to be attached to the stomach wall by surgery. Alternatively,the stretching device may be adapted to be placed on the outside of thestomach. In an embodiment, the stretching device comprises a firstengaging member adapted to engage a first part of the stomach wall and asecond engaging member adapted to engage a second part of the stomachwall close to but spaced from the first stomach part. The operationdevice is adapted to operate the first and second engaging member tomove away from each other to stretch the stomach wall portion betweenthe first and second parts of the stomach such that satiety is created.At least one of the first and second engaging members may be adapted toat least in part be invaginated by the stomach wall bystomach-to-stomach sutures or staplers holding the engaging member inplace. In addition, at least one of the first and second engagingmembers may be adapted to be kept in place by sutures or staplersbetween the engaging member and the stomach wall. Suitably, at least oneof the first and second engaging members comprises a tissue growthpromoting structure, preferably a net like structure, adapted to be incontact with the stomach wall to secure long term attachment of thestretching device to the stomach wall. In another embodiment, thestretching device comprises at least one expandable body adapted to beinvaginated by a portion of the patient's stomach wall, and theoperation device comprises a fluid reservoir, which is in fluidcommunication with a chamber of the body. The operation device isnon-invasively operable to distribute fluid from the fluid reservoir tothe chamber of the body to expand the body such that the stomach wallportion is stretched, when the body is invaginated. The fluid reservoirmay be operated by manually pressing it. The operation device maycomprise a reverse servo, wherein a small volume of fluid in the fluidreservoir is compressed with a higher force and the chamber of the bodycreates a movement of a larger total volume with less force per unit ofvolume. The fluid reservoir may be placed subcutaneously or in theabdomen, and may be regulated by moving a wall of the reservoir, forexample by a motor. Alternatively, a pump may be provided for pumpingfluid or air from the reservoir to the body's chamber. The term“reversed servo means” encompasses the definition of an device that iscontrolled with a higher force and a small stroke i.e. for examplemovement of a small amount of fluid with a high force controls a largeramount of fluid moving by means of very smaller force, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a strong force acting on a moving element having a shortstroke into a small force acting on another moving element having a longstroke. The reversed servo means is preferably used when manual controlof the device through intact skin is possible. In another embodiment theapparatus for treating a reflux disease and obesity comprises a largechamber in contact with one or more smaller chambers. The chambers areadapted to communicate with fluid or air being distributed between thechambers. A reversed servo for distributing fluid between the chambersmay be provided, wherein a small volume of fluid in the large chamber iscompressed with a higher force and the smaller chamber creates amovement of a larger total volume with less force per unit of volume.The large chamber may be adapted to be invaginated in the patient'sfundus stomach wall to also treat reflux disease by restricting movementof the cardiac notch towards the diaphragm muscle of the patient,whereas the small chambers function as stretching devices to treatobesity. The large chamber may distribute fluid or air to the smallchambers to cause them to expand and stretch the stomach fundus wall. Inanother embodiment, the stretching device comprises a mechanicalstretching device, wherein a motor for mechanically regulating thestretching device may be provided. The mechanically regulated stretchingdevice may be adapted to engage a first part of the stomach wall and asecond part of the stomach, wherein the mechanically regulatedstretching device comprises a joint mechanism adapted to be moved by theoperation device. Alternatively, the stretching device may comprise afirst engaging member adapted to engage a first part of the stomach walland a second engaging member adapted to engage a second part of thestomach wall close to but spaced from the first stomach part, whereinthe mechanical stretching device regulates the distance between thefirst and second parts of the stomach wall. As an alternative, thehydraulic means described above may be used for regulating such amechanical stretching device by the hydraulic distribution of fluid orair. The stretching device may be non-invasively adjustablepostoperatively. The operation device for operating the stretchingdevice may in its simplest form comprise a subcutaneous switch adaptedto be non-invasively operated by manually pressing the switch for theoperation of the stretching device. At least two operable stretchingdevices adapted to stretch at least two different portions of thestomach wall may be provided, wherein the apparatus is adapted to bepostoperatively and non-invasively regulated. Specifically, theapparatus may be regulated from time to time such that at a first timeone of the stretching devices stretches one of the portions of thestomach wall and at a second time the other of the stretching devicesstretches the other portion of the stomach wall. In another embodiment,the stretching device comprises a body adapted to fill out a volumedefined by wall portions of the stomach. The body suitably has roundedcontours without too sharp edges that would be damaging to the patient'sstomach wall. Where the body is to be invaginated it may have varyingcircumference to better be kept in place invaginated by stomach wallportions of the patient. The body may be shaped like an egg or like akidney. Generally, any kind of mechanical construction may be used. Anymechanical construction driven mechanically or hydraulically or anypneumatic construction may be used. Any motor or any pump or movingmaterial changing form when powered may be used to achieve the simplegoal of stretching a part of the stomach wall by moving at least twopart s of the stomach wall away from each other. Any kind of hydraulicoperation may be used. It will be appreciated that instead of hydraulicoperation; pneumatic operation can be used, wherein air instead ofhydraulic fluid is moved between a reservoir and a chamber formed by thestretching device. Preferably the reservoir has a locking position tokeep it in the desired position if it is handled by the patient. Tocompress the reservoir it preferably stays compressed and releases afterpressing again. Any kind of hydraulic solution may be used for thestretching device. The hydraulic solution may be driven by bothmechanically and powered with any motor or pump as well as manual. Ofcourse, just expanding an in-vaginated part of the stomach alsostretches away the stomach wall which also may be achieved bothmechanically, hydraulically, pneumatically and both being powered with amotor or pump or by manual force.

The present invention also provides a system for a combined treatment ofa reflux disease and obesity treatment system comprising an apparatusfor treating obesity as described above. The system may comprise asubcutaneous electric switch adapted to manually and non-invasivelycontrol a function of the apparatus for treating obesity. The system maycomprise a hydraulic device having a hydraulic reservoir, wherein theapparatus for treating obesity is adapted to non-invasively be regulatedby manually pressing the hydraulic reservoir. The system may comprise awireless remote control for controlling a function of the apparatus. Thewireless remote control comprises at least one external signaltransmitter and an internal signal receiver may be provided to beimplanted in the patient. The wireless remote control is adapted totransmit at least one wireless control signal for controlling theapparatus. The wireless control signal may comprise a frequency,amplitude, or phase modulated signal or a combination thereof, and ananalogue or a digital signal, or a combination of an analogue anddigital signal. Alternatively, the wireless control signal comprises anelectric or magnetic field, or a combined electric and magnetic field.The remote control may transmit a carrier signal for carrying thewireless control signal. The carrier signal may comprise digital,analogue or a combination of digital and analog signals. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analog control signal. The system may comprise a wirelessenergy transmitter for non-invasively energizing the apparatus withwireless energy. The energy transmitter transmits energy by at least onewireless energy signal. The wireless energy signal may comprise a wavesignal selected from the following: a sound wave signal, an ultrasoundwave signal, an electromagnetic wave signal, an infrared light signal, avisible light signal, an ultra violet light signal, a laser lightsignal, a micro wave signal, a radio wave signal, an x-ray radiationsignal and a gamma radiation signal. Alternatively, the wireless energysignal comprises an electric or magnetic field, or a combined electricand magnetic field. The wireless energy transmitter may transmit acarrier signal for carrying the wireless energy signal. The carriersignal may comprise digital, analogue or a combination of digital andanalog signals. The system may comprise an energy-transforming devicefor transforming the wireless energy from a first form into a secondform energy. The energy-transforming device may directly during energytransfer operate the apparatus with the second form energy. The secondform energy may comprise a direct current or pulsating direct current,or a combination of a direct current and pulsating direct current. Thesecond form energy may comprise an alternating current or a combinationof a direct and alternating current. An accumulator may be provided,wherein the second form energy is used at least partly to charge theaccumulator. The energy of the first or second form may comprisemagnetic energy, kinetic energy, sound energy, chemical energy, radiantenergy, electromagnetic energy, photo energy, nuclear energy or thermalenergy. One of the energy of the first form and the energy of the secondform may be non-magnetic, non-kinetic, non-chemical, non-sonic,non-nuclear or non-thermal. The system may comprise an energy sourceadapted to power the apparatus. The energy source may comprise aninternal energy source adapted to receive energy from an external energysource transmitting energy in a wireless mode. The internal energysource is charged by the energy in the wireless mode.

The system may comprise a feedback device for sending information frominside the patient's body to the outside thereof to give feedbackinformation related to a functional parameter. The system may comprise asensor sensing a parameter, such as a functional parameter of thesystem, which is correlated to the transfer of energy for charging aninternal energy source. An internal control unit may be provided forcontrolling the operation device of the apparatus in response to thesensor sensing a functional parameter. Alternatively, sensor senses aphysical parameter of the patient. The physical parameter may be one ofbody temperature, blood pressure, blood flow, heartbeats and breathing.The physical parameter sensor may be a pressure or motility sensor, or asensor sensing measure, bending, stretching or food intake. The internalcontrol unit may control the operation device in response to the sensorsensing the physical parameter. An internal control unit may be providedfor receiving information from the sensor. The operation device of theapparatus may comprise a motor or a pump. Specifically, the operationdevice may comprise an electric motor. The operation device may beelectrically powered, may be a hydraulic operation device or may be apneumatic operation device. The transmitted energy, directly in itswireless form may affect the operation device to create kinetic energyto operate the stretching device of the apparatus during energytransfer. The system may comprise a feedback device for sendinginformation from inside the patient's body to the outside thereof togive feedback information related to a functional parameter. The systemmay comprise an external data communicator and an implantable internaldata communicator communicating with the external data communicator,wherein the internal communicator is adapted to feed data related to theapparatus for treating obesity or the patient back to the external datacommunicator or the external data communicator feeds data to theinternal data communicator. The system may comprise implantableelectrical components including at least one voltage level guard and/orat least one constant current guard.

The present invention also provides methods of treating a patientsuffering from both a reflux disease and obesity. The methods can beperformed together with or in conjunction with earlier describedabdominal or intraluminar methods of treating a reflux disease. Theinvention provides methods listed below:

a) A method for surgically treating an obese patient, the methodcomprising the steps of:

cutting an opening in the abdominal wall of the patient,

dissecting an area around the stomach,

placing an apparatus for treating obesity as described above, engagingthe stomach wall of the patient, and

suturing the stomach wall.

The method may further comprise the additional step of:

postoperatively regulating the stretching device to stretch a part ofthe stomach wall to affect the appetite of the patient, wherein the stepof regulating the stretching device is controlled from outside thepatient's body.

The method may further comprise the additional steps of:

placing an additional apparatus for treating obesity as described above,engaging the stomach wall of the patient,

stretching a first part of the stomach wall by means of the apparatusfor treating obesity, and

stretching a second part of the stomach wall by means of the additionalapparatus for treating obesity.

b) A method for surgically placing an apparatus for treating obesity ina patient via a laparoscopic abdominal approach, the method comprisingthe steps of:

inserting a needle or a tube like instrument into the abdomen of thepatient's body, using the needle or a tube like instrument to fill thepatient's abdomen with gas thereby expanding the patient's abdominalcavity,

placing at least two laparoscopic trocars in the patient's body,

inserting a camera through one of the laparoscopic trocars into thepatient's abdomen,

inserting at least one dissecting tool through one of the at least twolaparoscopic trocars and dissecting an intended placement area of thepatient, and

placing an apparatus for treating obesity as described above, engagingthe stomach wall.

c) A method of using the system for treating obesity as described above,comprising the step of regulating the stretching device postoperativelyto stretch a portion of the stomach wall to affect the appetite of thepatient, wherein the step of regulating the stretching device isperformed non-invasively. The stretching device comprises a mechanicalor hydraulic stretching device. The hydraulic stretching device maycomprise a reservoir, for moving gel or gas or fluid to or from thestretching device. The reservoir may be placed subcutaneously for beingreached by the patients hand for moving fluid manually to or from thestretching device. The stretching device may be powered by an internalenergy source for stretching or releasing the stretching device, whereinby means of a control device controlling the power from an internalcontrol unit or from the outside the patient's body. A wireless energytransmitter for wireless transfer of energy powers the operation deviceto get the stretching device to directly during energy transfer causethe stretching device to stretch the stomach wall. A wireless energytransmitter for wireless transfer of energy charges the internal energysource. A reversed servo may be provided, wherein moving, in a closedhydraulic system, a small amount of fluid, a larger movement of fluid isachieved in a second larger closed hydraulic system, wherein the smallamount of fluid is moved with by a higher force per area unit than thelarge volume. An invaginated stretching device in the fundus stomachwall of the patient is adapted to be adjustable, wherein the stretchingdevice placed invaginated in the stomach fundus wall is adapted to beadjusted and stretching the stomach fundus wall thereby creatingsatiety.

The method may further comprise sending feedback information from insidethe body to the outside thereof to give feedback related to thefunctional parameters of the device. Alternatively, the method mayfurther comprise sending feedback information from inside the body tothe outside thereof to give feedback related to the physical parametersof the patient. The functional parameter of the device may be correlatedto the transfer of energy for charging the internal energy source. Thedevice is programmable from outside the patient's body.

The method may further comprise the steps of:

sensing a physical parameter of the patient or a functional parameter ofthe device, and

sending sensing information to a control unit adapted for regulating thestretching device.

The method may further comprise the steps of:

sensing a physical parameter of the patient or a functional parameter ofthe device, and

sending sensing information to a control unit adapted for regulating thecharging of the internal energy source.

The method may further comprise subcutaneously placing a reversed servohaving a small control reservoir and moving a small volume from thecontrol reservoir with a higher force per area unit, creating a largermovement of the stretching device with less force per area unit.

The method may further comprise performing the non-invasive regulationby manually pressing a subcutaneous switch.

The method may further comprise performing the non-invasive regulationby a wireless remote control.

The method may further comprise performing the non-invasive regulationby a wireless energy transmitter.

The method may further comprise powering the apparatus for treatingobesity by an internal energy source.

The method may further comprise powering the apparatus for treatingobesity by an external energy source transmitting wireless energy,wherein the energy source comprises an external energy sourcetransmitting wireless energy.

The method may further comprise transmitting wireless energy from anexternal energy source to charge a rechargeable internal energy source.

d) A method of using an apparatus as described above, wherein thestretching device comprises a main body including a large chamber incontact with one or more smaller reservoirs/chambers adapted to stretchthe stomach wall, wherein the chambers are adapted to communicate withfluid or air being moved between the chambers.

e) A method of using an apparatus as described above, wherein the largechamber are adapted to, with its main volume to be the stretchingdevice's most important volume and wherein, the small chambers are asthe stretching devices stretching the stomach wall to treat obesity,wherein the main chamber is communicating with fluid or gel to the smallchambers causing the stretching effect in the stomach fundus wallthereby treating obesity.

f) A method of using an apparatus as described above, comprisingtreating reflux disease by invaginating the large chamber with its mainvolume in the fundus stomach wall thereby restricting movement of thestomach notch towards the diaphragm muscle of the patient, andstretching the stomach fundus wall using the small chambers,communicating with fluid or air from the large chamber to the smallchambers causing a stretching effect in the stomach fundus wall therebytreating obesity.

In another aspect, the invention relates an apparatus to treat a refluxdevice and/or obesity of a patient having a stomach with a food cavity.The apparatus generally comprises at least one volume filling deviceadapted to be at least substantially invaginated by a stomach wallportion of the patient, wherein the volume filling device is adapted tobe placed on the outside of the stomach wall, so that the volume of thefood cavity is reduced in size by a volume substantially exceeding thevolume of the volume filling device, wherein the surface of the volumefilling device comprises a biocompatible material, wherein a substantialpart of the surface of the volume filling device is adapted to restagainst the outside of the stomach wall, and wherein the volume fillingdevice has a maximum circumference of at least 30 millimeters. Theapparatus preferably comprises a volume filling device comprising aninflatable device expandable to an expanded state. The inflatabledevice, preferably has an inlet port for a fluid or a gel and is adaptedto be connected to a gastroscopic instrument. The inlet port preferablycomprises a fluid connection adapted to interconnect the volume fillingdevice and the gastroscopic instrument. The volume filling device has anelongated shape. Alternatively, the volume filling device has a roundedshape, or a bent or curved shape. The volume filling device, preferablycomprises an elastic material. The volume filling device, preferablycomprises a bio-compatible material. Preferably, the volume fillingdevice comprises silicone. The volume filling device can be providedwith a coating of one or multiple layers, such as a Parylene coating, apolytetrafluoroethylene coating, or a polyurethane coating. The volumefilling device comprises a fluid that is adapted to be transformed intosolid state or fixed form. In one example the fluid is liquidpolyurethane. In another example, the fluid is isotonic. In anotherexample, the fluid comprises large molecules to prevent diffusion. Inanother example, the fluid comprises iodine molecules. The volumefilling device comprises a homogenous material. The volume fillingdevice can be a solid body, it can comprise an enclosure wall defining achamber, it can comprise a rigid outer surface, it can comprise anelastic outer surface, and it can comprise a flexible outer surface. Thevolume filling device preferably has a maximum circumference of at least50 millimeters, more preferably a circumference of at least 80millimeters. The volume filling device, preferably has a volume ofbetween 0.00001 and 0.001 m³, more preferably a volume of between0.00001 and 0.0002 m³. Preferably, the volume filling device isdeformable to a maximum diameter, so as to be inserted into alaparoscopic trocar. The volume filling device is adapted to be kept inplace by stomach-to-stomach sutures or staples to invaginate the devicein the stomach wall. The stomach-to-stomach sutures or staples areprovided with fixation portions exhibiting a structure adapted to be incontact with the stomach wall to promote growth in of human tissue tosecure the long term placement of the volume filling device attached tothe stomach wall. The structure preferably comprises a net likestructure. The volume filling device is adapted to be non-invasivelyadjustable postoperatively. In one embodiment, the volume filling devicehas varying circumference to be better adapted to be kept in placeinvaginated in the stomach wall of the patient. The apparatus accordingto can further comprise a stretching device placed outside the stomachwall and adapted to stretch a part of the stomach wall, therebyaffecting the patient's appetite, the apparatus further comprising afluid connection interconnecting the stretching device and the volumefilling device. In one embodiment, the volume filling device is adaptedto be placed outside the stomach wall via a gastroscopic instrument. Inone embodiment, the volume filling device comprises at least twointerconnectable portions, and wherein the volume filling device isadapted to be placed outside the stomach wall as separate portions. Inone embodiment, an outer surface layer of the volume filling devicecomprises polyurethane, Teflon®, or PTFE, or a combination thereof. Inone embodiment, the volume filling device is adapted to be destroyed byacid, preferably hydrochloric acid. In one embodiment, the volumefilling device comprises gel, preferably, the gel has a shore value ofless than 15. In one embodiment, the volume filling device comprises anattachment device adapted to co-operate with a gripping instrument. Inone embodiment, the volume filling device is adapted to be completelyinvaginated by the stomach wall of the patient. The apparatus canfurther comprise a fixating device adapted to fixate the food intakereducing device to the stomach wall to keep the volume filling device inplace, when the volume filling device is implanted. The volume fillingdevice has a volume of less than 0.0002 m³, preferably, a volume ofbetween 0.0001 and 0.001 m³. In one embodiment, the volume fillingdevice is adapted to be un-destroyed by acid, preferably hydrochloricacid. Preferably, the volume filling device has a circumference of atleast 120 mm, more preferably, of at least 150 mm, still more preferablyof at least 180 mm, and even more preferably, a circumference of atleast 220 mm. The volume filling device, preferably comprises a flexiblenon-elastic material. The apparatus preferably comprises a volumefilling device which comprises a fixation device adapted to be involvedin the fixation of the device to the stomach wall. In one embodiment,the volume filling device comprises two or more fixation devices adaptedto be involved in the fixation of the device to the stomach wall. In oneembodiment, the volume filling device comprises a holding device adaptedto be able to be held by an instrument and simplify the implantation ofthe device. In one embodiment, the volume filling device comprises twoor more holding devices adapted to be able to be held by an instrumentand simplify the implantation of the device. In one embodiment, thevolume filling device comprises at least one tube connected to thedevice. In one embodiment, the volume filling device comprises aninjection port for connecting to said tube.

The so described apparatus to treat a reflux device and/or obesity of apatient comprising at least one volume filling device can be combinedwith any feature disclosed in previous sections, such as, but notlimited to the stretch cardia stimulation devices. It is also conceivedthat the so described apparatus to treat a reflux device and/or obesityof a patient comprising at least one volume filling device can beimplanted by generally employing the abdominal or intraluminar methodsas outlined in previous sections of this document and that suitablefeatures of the earlier described movement restriction device can beemployed with the volume filling device.

It should be noted that any embodiment or part of embodiment or featureor method or associated system or part of system described herein may becombined in any combination.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting examples, and with reference to the accompanying drawings,in which:

FIGS. 1A-C are schematic views of various embodiments of an apparatusfor treating Gastroesophageal Reflux Disease implanted in a humanpatient.

FIGS. 2A-B are schematic views of various embodiments of an apparatusfor treating Gastroesophageal Reflux Disease implanted in a humanpatient.

FIGS. 3A-B are schematic views of various embodiment of an apparatus fortreating Gastroesophageal Reflux Disease implanted in a human patient.

FIGS. 4A-D are schematic views of embodiments of an apparatus fortreating Gastroesophageal Reflux Disease and obesity implanted in ahuman patient.

FIG. 5A-B is a schematic view of an embodiment of an apparatus fortreating Gastroesophageal Reflux Disease implanted in a human patient.

FIGS. 6A-D and 7-9 show alternative shapes of a movement restrictiondevice for treating Gastroesophageal Reflux Disease adapted to beimplanted in a human patient.

FIG. 10 is an overall view of a patient with an implanted movementrestriction device for treating Gastroesophageal Reflux Disease.

FIGS. 11-27 are schematic views of various ways of powering an apparatusfor treating Gastroesophageal Reflux Disease.

FIGS. 28-31, 32A-C, 33 and 34 A-C are schematic views of various ways ofarranging the hydraulic or pneumatic powering of an apparatus of theinvention for treating Gastroesophageal Reflux Disease.

FIG. 35 is a flowchart illustrating steps performed when implanting amovement restriction device for treating Gastroesophageal RefluxDisease.

FIGS. 36-41 shows methods for restoring the location of the cardia andthe fundus in a patient suffering from reflux disease.

FIGS. 42-46 show different shapes and features of a reflux treatmentdevice comprised in an apparatus according to the invention,

FIGS. 47a-d show a deflated inflatable reflux treatment device comprisedin an apparatus according to the invention and an instrument for placingthe reflux treatment device on the outside of the stomach wall of thepatient.

FIGS. 48a-i illustrate different steps of invaginating the inflatabledevice of FIG. 47a on the outside of a stomach wall of a patient,

FIG. 49 shows an embodiment wherein the reflux treatment apparatus isalso adapted to treat obesity.

FIGS. 50-51 show an embodiment wherein the reflux treatment apparatusadapted also for treating obesity

FIGS. 52 a-i illustrate different steps of invaginating the inflatabledevice of FIG. 47a on the inside of a stomach wall of a patient,

FIGS. 53 a-c show an instrument for creating an invagination of the wallof the stomach.

FIGS. 54-55 show an abdominal method for treating reflux disease.

DETAILED DESCRIPTION

FIG. 1A is a schematic view depicting an apparatus 11, including amovement restriction device 10 of a biocompatible material, for treatingreflux disease, in accordance with the invention, implanted in a humanpatient. In FIG. 1A, the device 10 is invaginated in the fundus. Thedevice 10 comprises a body 13 having an outer surface 15 suitable forresting against a portion of the outside wall 16 a of the stomach funduswall 16 in a position between the patient's diaphragm 18 and at least aportion of the lower part of the invaginated stomach fundus wall 16.Thus, with the device 10 invaginated in this fashion, movement of thecardiac notch of the patient's stomach towards the patient's diaphragmis restricted, thereby the cardia is prevented from sliding through thepatient's diaphragm opening into the patient's thorax 20 and thesupporting pressure against the patient's cardia sphincter muscleexerted from the patient's abdomen is maintained

The body 13 is inflatable and adapted to be inflated with a gel orfluid. A fluid or get receiving member for receiving fluid to inflatesaid movement restriction device may be provided. Alternatively, thebody 13 includes a homogenous material and be a solid body.Alternatively, the body 13 includes an outer wall in the form of anenclosure wall defining a chamber. The outer wall may be rigid, elasticor flexible. Where the outer wall is rigid, it is rigid enough tomaintain non-deformed when subject to forces created by stomachmovements.

The body 13 of the movement restriction device 10 can be affixed to thewall 16 a of the fundus 16 in a number of different ways. In theembodiment shown in FIG. 1A, the device 10 is invaginated in the fundusstomach wall from outside the stomach. After invagination, a firstfixation device consisting of a number of stomach-to-stomach sutures orstaples 22 a is applied to keep the invagination in tact in the shortterm. This allows the growth of human tissue to keep the invaginationintact over the long term.

There may optionally be a second fixation device consisting of a numberof sutures or staples 22 b that are provided between the wall 16 a ofthe fundus 16 and the wall 24 a of the oesophagus 24 to hold the device10 in said position between the patient's diaphragm 18 and at least aportion of the lower part of the invaginated stomach fundus wall 16 a.Thus, the device 10 is affixed in this position by this second fixationapparatus. A direct or indirect affixation of the device 10 to thediaphragm muscle 18 or associated muscles may be provided. As analternative, a direct or indirect affixation of the device 10 to theoesophagus His can be provided. Alternatively, or additionally, theremay be a third fixation device in the form of sutures or staples 22 cprovided between the wall 16 a of the fundus 16 and the diaphragm 18 tohold the device 10 in said position.

FIG. 1B shows an embodiment substantially similar to the one shown inFIG. 1A. In FIG. 1B the body 13 and invagination are, in addition to theaffixation 22, fixed by means of sutures and/or staples 22 c between thereflux body 13 and the diaphragm 18, to hold the device in positionabove the cardia 14.

FIG. 1C shows another embodiment substantially similar to the one shownin FIG. 1A. In FIG. 1C the reflux treatment device is held in place bystomach-to-stomach sutures or staplers 22 a that connects the wall 16 aof the fundus 16 to the wall 16 a of the fundus 16. In addition thereflux treatment device 10 is held in place by sutures 22 b or staplersfrom the wall 16 of the fundus 16 a to the wall of the esophagus 24 a,and by sutures or staples from the wall of the fundus 16 a to thediaphragm.

An alternative embodiment of an apparatus 17 for the treatment of refluxdisease in accordance with the invention is depicted in FIG. 2A. Thisembodiment is, in many aspects, similar to the one described above withreference to FIG. 1A-C. Thus, a movement restriction device 10 is shownimplanted in a human patient and invaginated in the fundus. However, inthe embodiment shown in FIG. 2A, the device 10 is invaginated from theinside of the stomach, instead of from outside of the stomach, as inFIG. 1A-C. The movement restriction device 10 comprises a body 13adapted to rest against a portion of the inside wall of the stomachfundus wall 16 in a position between the patient's diaphragm 18 and atleast a portion of the lower part of the invaginated stomach fundus wall16. In this embodiment, the body 13 is situated above the cardia area 14of a standing human or animal mammal patient. The body 13 of the device10 is shaped to rest against the wall 16 a of the fundus 16, andfurther, has an outer surface 15 suitable to rest against this funduswall. Thus, with the device 10 invaginated in this fashion as describedabove in connection with FIG. 1A, movement of the cardiac notch of thepatient's stomach towards the patient's diaphragm is restricted, therebythe cardia is prevented from sliding through the patient's diaphragmopening into the patient's thorax 20 and the supporting pressure againstthe patient's cardia sphincter muscle exerted from the patient's abdomenis maintained.

After invagination, a number of stomach-to-stomach sutures or staples 33a comprising a first fixation device are applied from inside the stomach16 to keep the invagination in tact in the short term. This allows thegrowth of human tissue, keeping the invagination in tact over the longterm. Additional sutures or staples 22 b comprising a second fixationdevice can be provided between a wall portion 16 b of the fundus 16forming part of the invagination of the device 10 and the wall 24 a ofthe oesophagus 24 to hold the device 10 in said position. Similarly, athird fixation device in the form of sutures or staples 22 c can beprovided between another wall portion 16 c of the fundus 16 forming pertof the invagination of the device 10 and the diaphragm 18 to hold thedevice 10 in said position.

An alternative embodiment is shown in FIG. 2B. This embodiment is inmany aspects similar to the one described with reference to FIG. 2A.However, here the sutures and staples 22 b and 33 a are all connected tothe fixator of the reflux treatment device 10. This embodiment lacksstomach-to-diaphragm sutures or staples.

An alternative an apparatus 19 for the treatment of reflux disease isdepicted in FIG. 3A. This alternative is in many aspects similar to theones described above with reference to FIGS. 1A-C and 2 A-B. Thus, amovement restriction device 10 is shown implanted in a human patient.The device 10 comprises a body 13 adapted to rest against a portion ofthe stomach fundus wall 16 in a position between the patient's diaphragm18 and stomach fundus wall 16. However, in this alternative, the device10 is not invaginated in the stomach 16. Instead, the affixation of thedevice 10 comprises an attachment structure 10 a, preferably a netlike-structure that is adapted to be in contact with the fundus stomachwall 16 a to promote the growth of human tissue to secure long termplacement of the reflux disease treatment device attached to the stomachwall. In the short term, a first fixation device in the form of suturesor staples 44 a may be provided between the attachment structure 10 aand the fundus wall 16 a to keep the attachment structure 10 a in place.

The attachment structure 10 a may be adapted for a second fixationdevice in the form of sutures or staples 44 b that are provided betweenthe wall 16 a of the fundus 16 and the wall 24 a of the oesophagus 24 tohold the device 10 in said position between the patient's diaphragm 18and stomach fundus wall 16. Similarly, the attachment structure 10 a mayalso be adapted for a third fixation device in the form of sutures orstaples 44 c that are provided between the wall 16 a of the fundus 16and the diaphragm 18, again, to hold the device 10 in said position.

An alternative embodiment is shown in FIG. 3B. This embodiment is inmany aspects similar to the one described with reference to FIG. 3A. Inthis embodiment, the reflux treatment device 10 is, like in FIG. 2A-Binvaginated from the inside of the stomach. The attachment structure 10a is positioned on the wall 16 a of the fundus 16 above and around theinvagination created by the reflux treatment device 10.

A alternative embodiment of an apparatus 21 for treatment of refluxdisease in accordance with the invention is depicted in FIG. 4A. Thisembodiment is in many aspects similar to the one described above withreference to FIG. 1A-C. In FIG. 4A, a view of a device 10 for treatmentof reflux disease in accordance with the invention is shown implanted ina human patient. In FIG. 4A, the movement restriction device 10 is againinvaginated in the fundus 16. The device 10 comprises a body 13 havingan outer surface 15 suitable for resting against a portion of theoutside wall 16 a of the stomach fundus wall 16 in a position betweenthe patient's diaphragm 18 and at least a portion of the lower part ofthe invaginated stomach fundus wall 16. The body 13 is shaped to restagainst the outside wall 16 a of the fundus 16. Thus, with the device 10invaginated in this fashion, movement of the cardiac notch of thepatient's stomach towards the patient's diaphragm is restricted, therebythe cardia is prevented from sliding through the patient's diaphragmopening into the patient's thorax 20 and the supporting pressure againstthe patient's cardia sphincter muscle exerted from the patient's abdomenis maintained.

In the embodiment of FIG. 4A, as in the embodiment of FIG. 1A, afterinvagination of the device 10 in the fundus 16, a first fixation deviceconsisting of a number of stomach-to-stomach sutures or staples 22 a isapplied to keep the invagination in tact in the short term. A secondfixation device consisting of a number of sutures or staples 22 b isprovided to hold the device 10 in said position between the patient'sdiaphragm 18 and at least a portion of the lower part of the invaginatedstomach fundus wall 16. Additionally, a third fixation device in theform of sutures or staples 22 c may be provided between the wall 16 a ofthe fundus 16 and the diaphragm 18, again, to hold the device 10 in saidposition.

In the embodiment depicted in FIG. 4A, the size of the movementrestriction device 10 can be regulated while being implanted. The device10 is associated with a hydraulic reservoir 52 connected to the device10 by a lead 52 b, whereby a non-invasive regulation can be performed bymanually pressing the reservoir 52. The device 10 is, in turn, connectedto one or more smaller chambers 10 b.

Furthermore, the embodiment above may alternatively be used to alsotreat obesity. The apparatus may, in this embodiment, be adapted totreat obesity by using the volume of the movement restriction body 13 tocontain a fluid, and further using one or more smaller chambers 10 bconnected to the body 13 with a pump to be filled with fluid to stretchthe fundus wall to create satiety. The small chambers 10 b are alsoadapted to be invaginated to in the fundus stomach wall, and when filledwith fluid, an expansion occurs that results in human sensor feedbackcreating satiety. By placing the small hydraulic reservoir/pumpsubcutaneously in the patient, the patient is able to pump hydraulicfluid to fill the small chambers to feel full on request.

An alternative embodiment is shown in FIG. 4B. This embodiment issubstantially similar to the one shown in FIG. 4A but differs in how thereflux treatment device 10 and chambers 10 b are controlled. Here, thechambers 10 b are not controlled by a subcutaneous pump but a poweredinternal control unit 56. The internal control unit 56 comprises meansfor the patient to control the device 10 in how it shall be usedregarding treatment of reflux and/or obesity. It may also comprise meansof supplying power to the device.

The internal control unit 56 may comprise a battery 70, an electricswitch 72, a motor/pump 44, a reservoir 52, an injection port 1001. Anenergy transmission device 34 with a remote control is adapted forcontrolling and powering the device. The items being selected dependingon the circumstances, e.g. if the device is electrically, hydraulically,pneumatically or mechanically operated.

The control unit may receive input from any sensor 76, specially apressure sensor. Any type of sensor may be supplied. The internalcontrol unit 56 preferable includes intelligence in forms of a FPGA orMCU or ASIC or any other circuit, component or memory (For a moreextensive description see below under “system”).

FIG. 4C shows essentially the same as FIG. 4A with the difference thatthere is one small chamber 10 b instead of two small chambers as in 4A.FIG. 4C shows the small chamber 10 b in its empty state whereas FIG. 4Dshows the small chambers 10 b when it has been filled and enlarged tocreate satiety.

Yet an alternative embodiment of an apparatus 23 for the treatment ofreflux disease in accordance with the invention is depicted in FIG. 5A.This embodiment is, again, in many aspects similar to the one describedabove with reference to FIG. 1A-C.

Thus, as in the embodiment of FIG. 1A, a movement restriction device 10,which is invaginated in the fundus, is comprised of a body 13 having anouter surface 15 suitable for resting against a portion of the outsidewall 16 a of the stomach fundus wall 16 in a position between thepatient's diaphragm 18 and at least a portion of the lower part of theinvaginated stomach fundus wall 16. The body 13 of the device 10 isshaped to rest against the outside wall 16 a of the fundus 16 and has agenerally smooth outer surface 15 suitable for resting against thisfundus wall. And, again, after invagination of the device 10 in thefundus 16, a first fixation device consisting of a number ofstomach-to-stomach sutures or staples 22 a is applied to keep theinvagination in tact in the short term. A second fixation deviceconsisting of a number of sutures or staples 22 b applied between thewall 16 a of the fundus 16 and the wall 24 a of the oesophagus 24 isprovided to hold the device 10 in said position.

In the alternative embodiment shown in FIG. 5A, the apparatus 23 furthercomprises a stimulation device 26 for sending out stimulation pulsesadapted to stimulate the cardia muscle to further close the cardia toadditionally prevent reflux disease. The apparatus 23 comprises at leastone conductor 26 a and at least one electrode 26 b adapted to receivethe stimulation pulses.

The stimulation device 26 preferably comprises an electronic circuit andan energy source, which in the preferred embodiment is provided in thedevice 10.

The stimulation device 26 preferably sends stimulation pulses as a trainof pulses, wherein the pulse train is adapted to be repeated with a timebreak in between, the break extending the break between each pulse inthe pulse train.

FIG. 5B shows essentially the same embodiment as in FIG. 5A, with theaddition of an internal control unit 56, a remote control 28 and anexternal energy transmission device 34. The internal control unit 56 isconnected to the stimulation device with a power lead 56 b. The internalcontrol unit 57 may comprise a battery 70 and an electric switch 72 andother components described below under “system”.

The reflux disease treatment device 10 can, in accordance with oneembodiment of the present invention, be formed as a generally egg shapedbody, as is shown in FIG. 6A. The reflux disease treatment device 10can, in accordance with another embodiment of the present invention,also be formed as an egg or sphere shaped body with an indent in itsmiddle, as is shown in FIG. 6B. The reflux disease treatment device 10can, in accordance with yet another embodiment of the present invention,further be formed as a slightly bent egg shaped body as shown in FIG.6C.

The reflux disease treatment device 10 can, in accordance with a furtherembodiment of the present invention, be formed as a generallyspherically-shaped body, as shown in FIG. 6D.

As discussed above, the reflux treatment device 10 is fixed in aposition which is above the esophagus in a standing patient. To enablethis, one embodiment of the reflux treatment shown in FIG. 7 comprises afixator 10 d that may, for example, serve as an attachment point forsutures or staples. The fixator may be a loop or a ridge with or withoutholes or have any other shape that makes it suitable for fixating thereflux treatment device 10.

FIG. 8 show an embodiment of the reflux treatment device 10 where it isadjustable by a hydraulic means, and 10 e is an injection port wherehydraulic fluid can be in order to expand the device. Alternatively, inone embodiment the reflux treatment device 10 can be inflated from asmall size to a larger size during a surgical procedure where it isadvantageous that the device is initially of small size, for exampleduring a laparoscopic procedure. In such an embodiment, any fillingmaterial, solid, liquid or gas many injected trough the injection port10 e in order for the reflux treatment device 10 to achieve its finalshape.

FIG. 9 shows an embodiment where the reflux treatment device 10 has asunken ridge 10 f adapted to being held with a surgical tool. This is tobe used, for example, during a surgical procedure when the refluxtreatment device is implanted.

When the reflux disease treatment device 10 is generally spherical,whereby it can be made to wholly or partly encompass the esophagus, theinner diameter D of the reflux disease treatment device 10, ispreferably such that it can encompass the esophagus and at least a partof the fundus so that the device does not rest directly against the wallof the esophagus when implanted.

The movement restriction device 10 may take any form that enables thedevice 10 to rest in a position in which movement of the cardiac notchof the patient's stomach towards the patient's diaphragm is restricted,thereby the cardia is prevented from sliding through the patient'sdiaphragm opening into the patient's thorax and the supporting pressureagainst the patient's cardia sphincter muscle exerted from the patient'sabdomen is maintained

System

An energy and operation system, generally designated 28, to beincorporated in the apparatus according to the invention, will now bedescribed with reference to FIGS. 10-27.

The system 28 shown in FIG. 10 comprises an internal energy source inthe form of an implanted energy transforming device 30 adapted to supplyenergy consuming components of the reflux disease treatment apparatuswith energy via a power supply line 32. An external energy transmissiondevice 34 includes a wireless remote control transmitting a wirelesssignal, which is received by a signal receiver which may be incorporatedin the implanted energy transforming device 30, or be separate. Theimplanted energy transforming device 30 transforms energy from thesignal into electric energy which is supplied via the power supply line32.

The system 28 of FIG. 10 is shown in a more generalized block diagramform in FIG. 11, wherein the patient's skin 36, generally shown by avertical line, separates the interior of the patient 29 to the right ofthe line from the exterior to the left of the line.

FIG. 11 shows a simplified block diagram showing the movementrestriction device 10, the energy transforming device 30 powering thedevice 10 via power supply line 32, and the external energy transmissiondevice 34.

FIG. 12 shows an embodiment of the invention identical to that of FIG.11, except that a reversing device in the form of an electric switch 38operable by polarized energy also is implanted in the patient 29 forreversing the device 10. The wireless remote control of the externalenergy transmission device 34 transmits a wireless signal that carriespolarized energy and the implanted energy transforming device 30transforms the wireless polarized energy into a polarized current foroperating the electric switch 38. When the polarity of the current isshifted by the implanted energy transforming device 30 the electricswitch 38 reverses the function performed by the device 10.

FIG. 13 shows an embodiment of the invention identical to that of FIG.11, except that an operation device 40 implanted in the patient forregulating the reflux disease treatment device 10 is provided betweenthe implanted energy transforming device 30 and the device 10. Thisoperation device can be in the form of a motor 40, such as an electricservomotor. The motor 40 is powered with energy from the implantedenergy transforming device 30, as the remote control of the externalenergy transmission device 34 transmits a wireless signal to thereceiver of the implanted energy transforming device 30.

FIG. 14 shows an embodiment of the invention identical to that of FIG.11, except that it also comprises an operation device is in the form ofan assembly 42 including a motor/pump unit 78 and a fluid reservoir 46is implanted in the patient. In this case the device 10 is hydraulicallyoperated, i.e. hydraulic fluid is pumped by the motor/pump unit 44 fromthe fluid reservoir 46 through a conduit 48 to the device 10 to operatethe device, and hydraulic fluid is pumped by the motor/pump unit 44 backfrom the device 10 to the fluid reservoir 46 to return the device 10 toa starting position. The implanted energy transforming device 30transforms wireless energy into a current, for example a polarizedcurrent, for powering the motor/pump unit 44 via an electric powersupply line 50.

Instead of a hydraulically operated movement restriction device 10, itis also envisaged that the operation device comprises a pneumaticoperation device. In this case, pressurized air can be used forregulation and the fluid reservoir is replaced by an air chamber and thefluid is replaced by air.

In all of these embodiments the energy transforming device 30 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the apparatus.

The external energy transmission device 34 is preferably wireless andmay include a remotely controlled control device for controlling thedevice 10 from outside the human body.

Such a control device may include a wireless remote control as well as amanual control of any implanted part to make contact with by thepatient's hand most likely indirect for example a button to press placedunder the skin.

FIG. 15 shows an embodiment of the invention comprising the externalenergy transmission device 34 with its wireless remote control, thedevice 10, in this case hydraulically operated, and the implanted energytransforming device 30, and further comprising a hydraulic fluidreservoir 52, a motor/pump unit 44 and an reversing device in the formof a hydraulic valve shifting device 54, all implanted in the patient.Of course the hydraulic operation could easily be performed by justchanging the pumping direction and the hydraulic valve may therefore beomitted. The remote control may be a device separated from the externalenergy transmission or included in the same. The motor of the motor/pumpunit 44 is an electric motor. In response to a control signal from thewireless remote control of the external energy transmission device 34,the implanted energy transforming device 30 powers the motor/pump unit44 with energy from the energy carried by the control signal, wherebythe motor/pump unit 44 distributes hydraulic fluid between the hydraulicfluid reservoir 52 and the device 10. The remote control of the externalenergy transmission device 34 controls the hydraulic valve shiftingdevice 54 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 44 fromthe hydraulic fluid reservoir 52 to the device 10 to operate the device10, and another opposite direction in which the fluid is pumped by themotor/pump unit 44 back from the device 10 to the hydraulic fluidreservoir 52 to return the device 10 to a starting position.

FIG. 16 shows an embodiment of the invention identical to that of FIG.15, except that an internal control unit 56 controlled by the wirelessremote control of the external energy transmission device 34, anaccumulator 58 and a capacitor 60 also are implanted in the patient. Theinternal control unit 56 arranges storage of electric energy receivedfrom the implanted energy transforming device 30 in the accumulator 58,which supplies energy to the device 10. In response to a control signalfrom the wireless remote control of the external energy transmissiondevice 34, the internal control unit 56 either releases electric energyfrom the accumulator 58 and transforms the released energy via powerlines 62 and 64, or directly transforms electric energy from theimplanted energy transforming device 30 via a power line 66, thecapacitor 60, which stabilizes the electric current, a power line 68 andthe power line 64, for the operation of the device 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the device 10 to stretch the stomach according toa pre-programmed time-schedule or to input from any sensor sensing anypossible physical parameter of the patient or any functional parameterof the device.

In accordance with an alternative, the capacitor 60 in the embodiment ofFIG. 16 may be omitted. In accordance with another alternative, theaccumulator 58 in this embodiment may be omitted.

FIG. 17 shows an embodiment of the invention identical to that of FIG.10, except that a battery 70 for supplying energy for the operation ofthe device 10 and an electric switch 72 for switching the operation ofthe device 10 also are implanted in the patient. The electric switch 72is operated by the energy supplied by the implanted energy transformingdevice 30 to switch from an off mode, in which the battery 70 is not inuse, to an on mode, in which the battery 70 supplies energy for theoperation of the device 10.

FIG. 18 shows an embodiment of the invention identical to that of FIG.16, except that an internal control unit 56 controllable by the wirelessremote control of the external energy transmission device 34 also isimplanted in the patient. In this case, the electric switch 72 isoperated by the energy supplied by the implanted energy transformingdevice 30 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 56 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 56 to releaseelectric energy from the battery 70 for the operation of the device 10.

FIG. 19 shows an embodiment of the invention identical to that of FIG.17, except that an accumulator 58 is substituted for the battery 70 andthe implanted components are interconnected differently. In this case,the accumulator 58 stores energy from the implanted energy transformingdevice 30. In response to a control signal from the wireless remotecontrol of the external energy transmission device 34, the internalcontrol unit 56 controls the electric switch 72 to switch from an offmode, in which the accumulator 58 is not in use, to an on mode, in whichthe accumulator 58 supplies energy for the operation of the device 10.

FIG. 20 shows an embodiment of the invention identical to that of FIG.18, except that a battery 70 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the external energytransmission device 34, the internal control unit 56 controls theaccumulator 58 to deliver energy for operating the electric switch 72 toswitch from an off mode, in which the battery 70 is not in use, to an onmode, in which the battery 70 supplies electric energy for the operationof the device 10.

Alternatively, the electric switch 72 may be operated by energy suppliedby the accumulator 58 to switch from an off mode, in which the wirelessremote control is prevented from controlling the battery 70 to supplyelectric energy and is not in use, to a standby mode, in which thewireless remote control is permitted to control the battery 70 to supplyelectric energy for the operation of the device 10.

It should be understood that the switch should be interpreted in itsbroadest embodiment. This means an FPGA or a DA converter or any otherelectronic component or circuit may switch power on and off preferablybeing controlled from outside the patient's body or by an internalcontrol unit.

FIG. 21 shows an embodiment of the invention identical to that of FIG.17, except that a motor 40, a mechanical reversing device in the form ofa gear box 74, and an internal control unit 56 for controlling the gearbox 74 also are implanted in the patient. The internal control unit 56controls the gear box 74 to reverse the function performed by the device10 (mechanically operated). Even simpler is to switch the direction ofthe motor electronically.

FIG. 22 shows an embodiment of the invention identical to that of FIG.20 except that the implanted components are interconnected differently.Thus, in this case, the internal control unit 56 is powered by thebattery 70 when the accumulator 58, suitably a capacitor, activates theelectric switch 72 to switch to an on mode. When the electric switch 72is in its on mode the internal control unit 56 is permitted to controlthe battery 70 to supply, or not supply, energy for the operation of thedevice 10.

FIG. 23 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the device 10, the internal control unit 56, motoror pump unit 44, and the external energy transmission device 34including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the internal control unit 56, which in turn controls thevarious implanted components of the apparatus.

A feedback device, preferably in the form of a sensor 76, may beimplanted in the patient for sensing a physical parameter of thepatient, such as a contraction wave in the oesophagus informing thepatient is eating. The internal control unit 56, or alternatively theexternal wireless remote control of the external energy transmissiondevice 34, may control the device 10 in response to signals from thesensor 76. A transceiver may be combined with the sensor 76 for sendinginformation on the sensed physical parameter to the external wirelessremote control. The wireless remote control may comprise a signaltransmitter or transceiver and the internal control unit 56 may comprisea signal receiver or transceiver. Alternatively, the wireless remotecontrol may comprise a signal receiver or transceiver and the internalcontrol unit 56 may comprise a signal transmitter or transceiver. Theabove transceivers, transmitters and receivers may be used for sendinginformation or data related to the device 10 from inside the patient'sbody to the outside thereof.

Alternatively, the sensor 76 may be arranged to sense a functionalparameter of the device 10.

Where the motor/pump unit 44 and battery 70 for powering the motor/pumpunit 44 are implanted, the battery 70 may be equipped with a transceiverfor sending information on the condition of the battery 70. To be moreprecise, when charging a battery or accumulator with energy feed backinformation related to said charging process is sent and the energysupply is changed accordingly.

FIG. 24 shows an alternative embodiment wherein the device 10 isregulated from outside the patient's body. The system 28 comprises amovement restriction device 10 connected to a battery 70 via asubcutaneous switch 80. Thus, the regulation of the device 10 isperformed non-invasively by manually pressing the subcutaneous switch,whereby the operation of the device 10 is switched on and off. It willbe appreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.

FIG. 25 shows an alternative embodiment, wherein the system 28 comprisesa movement restriction device 10 in fluid connection with a hydraulicfluid reservoir 52. Non-invasive regulation is performed by manuallypressing the hydraulic reservoir connected to the device 10.

A further embodiment of a system to be incorporated in the apparatusaccording to the invention comprises a feedback device for sendinginformation from inside the patient's body to the outside thereof togive feedback information related to at least one functional parameterof the movement restriction device or apparatus or a physical parameterof the patient, thereby optimizing the performance of the apparatus.

One preferred functional parameter of the device is correlated to thetransfer of energy for charging the internal energy source.

In FIG. 26, an arrangement is schematically illustrated for supplying anaccurate amount of energy to a system 28 implanted in a patient, whoseskin 36 is indicated by a vertical line. A movement restriction device10 is connected to an implanted energy transforming device 30, likewiselocated inside the patient, preferably just beneath the patient's skin36. Generally speaking, the implanted energy transforming device 30 maybe placed in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy transforming device 30 is adapted to receive wireless energy Etransmitted from an external energy source 34 a provided in the externalenergy transmission device 34 located outside the patient's skin 36 inthe vicinity of the implanted energy transforming device 30.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 34 a and an adjacent secondary coil arranged inthe implanted energy transforming device 30. When an electric current isfed through the primary coil, energy in the form of a voltage is inducedin the secondary coil which can be used to operate a movementrestriction device, e.g. after storing the incoming energy in an energystoring device or accumulator, such as a battery or a capacitor.However, the present invention is generally not limited to anyparticular energy transfer technique, TET devices or energy storingdevices, and any kind of wireless energy may be used.

The amount of energy received inside the body to the device may becompared with the energy used by the device. The term used by the deviceis then understood to include also energy stored by the device. Theamount of transferred energy can be regulated by means of an externalcontrol unit 34 b controlling the external energy source 34 a based onthe determined energy balance, as described above. In order to transferthe correct amount of energy, the energy balance and the required amountof energy can be determined by means of an internal control unit 56connected to the reflux disease treatment device 10. The internalcontrol unit 56 may thus be arranged to receive various measurementsobtained by suitable sensors or the like, not shown, measuring certaincharacteristics of the r10, somehow reflecting the required amount ofenergy needed for proper operation of the device 10. Moreover, thecurrent condition of the patient may also be detected by means ofsuitable measuring devices or sensors, in order to provide parametersreflecting the patient's condition. Hence, such characteristics and/orparameters may be related to the current state of the device 10, such aspower consumption, operational mode and temperature, as well as thepatient's condition reflected by, e.g., body temperature, bloodpressure, heartbeats and breathing.

Furthermore, an energy storing device or accumulator 58 may optionallybe connected to the implanted energy transforming device 30 foraccumulating received energy for later use by the device 10.Alternatively or additionally, characteristics of such an accumulator,also reflecting the required amount of energy, may be measured as well.The accumulator may be replaced by a battery, and the measuredcharacteristics may be related to the current state of the battery, suchas voltage, temperature, etc. In order to provide sufficient voltage andcurrent to the device 10, and also to avoid excessive heating, it isclearly understood that the battery should be charged optimally byreceiving a correct amount of energy from the implanted energytransforming device 30, i.e., not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 56. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 56 is adapted to determine the energybalance and/or the currently required amount of energy, (either energyper time unit or accumulated energy) based on measurements made by theabove-mentioned sensors or measuring devices on the reflux diseasetreatment device 10, or the patient, or an energy storing device ifused, or any combination thereof. The internal control unit 56 isfurther connected to an internal signal transmitter 82, arranged totransmit a control signal reflecting the determined required amount ofenergy, to an external signal receiver 34 c connected to the externalcontrol unit 34 b. The amount of energy transmitted from the externalenergy source 34 a may then be regulated in response to the receivedcontrol signal.

Alternatively, sensor measurements can be transmitted directly to theexternal control unit 34 b wherein the energy balance and/or thecurrently required amount of energy can be determined by the externalcontrol unit 34 b, thus integrating the above-described function of theinternal control unit 56 in the external control unit 34 b. In thatcase, the internal control unit 56 can be omitted and the sensormeasurements are supplied directly to the internal signal transmitter 82which sends the measurements over to the external signal receiver 34 cand the external control unit 34 b. The energy balance and the currentlyrequired amount of energy can then be determined by the external controlunit 34 b based on those sensor measurements.

Hence, the present solution employs the feed back of informationindicating the required energy, which is more efficient than previoussolutions because it is based on the actual use of energy that iscompared to the received energy, e.g. with respect to the amount ofenergy, the energy difference, or the energy receiving rate as comparedto the energy rate used by the device 10. The device 10 may use thereceived energy either for consuming or for storing the energy in anenergy storage device or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance.

However, such parameters may also be needed per se for any actions takeninternally to specifically operate the device.

The internal signal transmitter 82 and the external signal receiver 34 cmay be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 82 and the externalsignal receiver 34 c may be integrated in the implanted energytransforming device 30 and the external energy source 34 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

To conclude, the energy supply arrangement illustrated in FIG. 26 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 56. A control signal reflectingthe required amount of energy is also created by the internal controlunit 56, and the control signal is transmitted from the internal signaltransmitter 82 to the external signal receiver 34 c. Alternatively, theenergy balance can be determined by the external control unit 34 binstead depending on the implementation, as mentioned above. In thatcase, the control signal may carry measurement results from varioussensors. The amount of energy emitted from the external energy source 34a can then be regulated by the external control unit 34 b, based on thedetermined energy balance, e.g. in response to the received controlsignal. This process may be repeated intermittently at certain intervalsduring ongoing energy transfer, or may be executed on a more or lesscontinuous basis during the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 34 a, suchas voltage, current, amplitude, wave frequency and pulsecharacteristics.

A method is thus provided for controlling transmission of wirelessenergy supplied to an electrically operable reflux disease treatmentdevice implanted in a patient. The wireless energy E is transmitted froman external energy source located outside the patient and is received byan internal energy receiver located inside the patient, the internalenergy receiver being connected to the device 10 for directly orindirectly supplying received energy thereto. An energy balance isdetermined between the energy received by the internal energy receiverand the energy used for the device 10. The transmission of wirelessenergy E from the external energy source is then controlled based on thedetermined energy balance.

A system is also provided for controlling transmission of wirelessenergy supplied to an electrically operable movement restriction device10 implanted in a patient. The system is adapted to transmit thewireless energy E from an external energy source located outside thepatient which is received by an implanted energy transforming devicelocated inside the patient, the implanted energy transforming devicebeing connected to the device 10 for directly or indirectly supplyingreceived energy thereto. The system is further adapted to determine anenergy balance between the energy received by the implanted energytransforming device and the energy used for the device 10, and controlthe transmission of wireless energy E from the external energy source,based on the determined energy balance.

The functional parameter of the device is correlated to the transfer ofenergy for charging the internal energy source.

In yet an alternative embodiment, the external source of energy iscontrolled from outside the patient's body to release electromagneticwireless energy, and released electromagnetic wireless energy is usedfor operating the device 10.

In another embodiment, the external source of energy is controlling fromoutside the patient's body to release non-magnetic wireless energy, andreleased non-magnetic wireless energy is used for operating the device10.

Those skilled in the art will realize that the above various embodimentsaccording to FIGS. 14-26 could be combined in many different ways. Forexample, the electric switch 38 operated polarized energy could beincorporated in any of the embodiments of FIGS. 12, 15-21, the hydraulicvalve shifting device 54 could be incorporated in the embodiment of FIG.24, and the gear box 74 could be incorporated in the embodiment of FIG.33. It should be noted that the switch simply could mean any electroniccircuit or component.

Wireless transfer of energy for operating the movement restrictiondevice 10 has been described to enable non-invasive operation. It willbe appreciated that the device 10 can be operated with wire bound energyas well. One such example is shown in FIG. 26, wherein an externalswitch 84 is interconnected between the external energy source 34 a andan operation device, such as an electric motor regulating the device 10,by means of power lines 86 and 88. An external control unit 34 bcontrols the operation of the external switch to effect proper operationof the device 10.

Hydraulic or Pneumatic Powering

FIGS. 28-31 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering a movement restriction deviceaccording to the invention.

FIG. 28 shows a system for treating reflux disease as described abovewith. The system comprises a device 10 and further a separate regulationreservoir 46, a one way pump 44 and an alternate valve 54.

FIG. 29 shows the device 10 and a fluid reservoir 46. By moving the wallof the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the device may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 30 shows the device 10, a two way pump 44 and the regulationreservoir 46.

FIG. 31 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 46 and a servo reservoir 90. The servoreservoir 90 mechanically controls a movement restriction device 10 viaa mechanical interconnection 94. The device 10 has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 92 in fluid connection with the device 10. Alternatively, thecavity contains compressible gas, which can be compressed and expandedunder the control of the servo reservoir 90.

The servo reservoir 90 can also be part of the device itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This reflux disease treatment system isillustrated in FIG. 32-c. In FIG. 31, a flexible subcutaneous regulationreservoir 46 is shown connected to a bulge shaped servo reservoir 90 bymeans of a conduit 48. This bellow shaped servo reservoir 90 iscomprised in a flexible movement restriction device 10. In the stateshown in FIG. 32, the servo reservoir 90 contains a minimum of fluid andmost fluid is found in the regulation reservoir 46. Due to themechanical interconnection between the servo reservoir 90 and the device10, the outer shape of the device 10 is contracted, i.e., it occupiesless than its maximum volume. This maximum volume is shown with dashedlines in the figure.

FIG. 32 shows a state wherein a user, such as the patient in with thedevice is implanted, presses the regulation reservoir 46 so that fluidcontained therein is brought to flow through the conduit 48 and into theservo reservoir 90, which, thanks to its bellow shape, expandslongitudinally. This expansion in turn expands the device 10 so that itoccupies its maximum volume, thereby stretching the stomach wall (notshown), which it contacts.

The regulation reservoir 46 is preferably provided with means 46 a forkeeping its shape after compression. This means, which is schematicallyshown in the figure, will thus keep the device 10 in a stretchedposition also when the user releases the regulation reservoir. In thisway, the regulation reservoir essentially operates as an on/off switchfor the reflux disease treatment system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 33 and 34. The block diagram shownin FIG. 33 comprises with a first closed system controlling a secondclosed system. The first system comprises a regulation reservoir 46 anda servo reservoir 90. The servo reservoir 90 mechanically controls alarger adjustable reservoir 92 via a mechanical interconnection 94. Amovement restriction device 10 having an expandable/contactable cavityis in turn controlled by the larger adjustable reservoir 92 by supply ofhydraulic fluid from the larger adjustable reservoir 92 in fluidconnection with the device 10.

An example of this embodiment will now be described with reference toFIG. 34. Like in the previous embodiment, the regulation reservoir isplaced subcutaneous under the patient's skin and is operated by pushingthe outer surface thereof by means of a finger. The regulation reservoir46 is in fluid connection with a bellow shaped servo reservoir 90 bymeans of a conduit 48. In the first closed system 46, 48, 90 shown inFIG. 32a , the servo reservoir 90 contains a minimum of fluid and mostfluid is found in the regulation reservoir 46.

The servo reservoir 90 is mechanically connected to a larger adjustablereservoir 92, in this example also having a bellow shape but with alarger diameter than the servo reservoir 90. The larger adjustablereservoir 92 is in fluid connection with the device 10. This means thatwhen a user pushes the regulation reservoir 46, thereby displacing fluidfrom the regulation reservoir 46 to the servo reservoir 90, theexpansion of the servo reservoir 90 will displace a larger volume offluid from the larger adjustable reservoir 92 to the device 10. In otherwords, in this reversed servo, a small volume in the regulationreservoir is compressed with a higher force and this creates a movementof a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.32a-c , the regulation reservoir 46 is preferably provided with means 46a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the device 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the reflux disease treatment system.

In FIG. 35, a flow chart illustrating steps performed when implanting adevice in accordance with the present invention. First in a step 102, anopening is cut in the abdominal wall. Next, in a step 104 an area aroundthe stomach is dissected. Thereupon, in a step 106 at least one movementrestriction device in accordance with the invention is placed in contactwith the stomach wall, in particular the fundus wall. The stomach wallis then sutured in a step 108.

Method for the Restoration of the Location of the Cardia and the Fundus

FIG. 36 shows how an instrument 200 having at least one flexible part201 is introduced into the esophagus 24 of a patient that is sufferingfrom a hiatal hernia 202 where a part of the esophagus 24 and fundus 16that is supposed to be located below the diaphragm 18 has moved throughthe hiatus opening 18 a to a position above the diaphragm 18.

In FIG. 37 it is shown how, in a subsequent step, a member 203 having alarger cross sectional area than said instrument 200 is released fromthe instrument 200. The member 203 is adapted as to have across-sectional that is larger than the opening of the cardia 14. Thiscan be achieved by radial expansion of the member 203. The instrument200 is then pushed in a distal direction so that the cardia 14 and thefundus 16, or part of fundus 16, incorrectly located above diaphragm 18,slide through the hiatus opening 18 a back to a correct position belowthe diaphragm 18.

FIG. 38 shows an alternative method to the one shown in FIG. 37 which isan embodiment of the invention. In many aspects, this figure is similarto FIG. 37. In FIG. 38, the instrument 200 is adapted to release aballoon member 204 at the end 205 of the instrument 200 in the lowerpart of the stomach 206, and using the balloon member 204 to push theinstrument 200 against the lower wall part of the stomach 207 so thatthe cardia 14 and the fundus 16 or part of fundus 16 slide through thehiatus opening 18 a to a position below the diaphragm 18.

FIG. 39 shows yet an alternative method which is an embodiment of theinvention. Again, this figure is in many aspects similar to FIG. 37.However, in FIG. 39 the method involves attaching the member 203 to thewall of the stomach 207 by a fixation 208. As described above theinstrument is then pushed in a distal direction so the cardia 14 and thefundus 16 or, part of fundus 16, slides below the diaphragm 18.

FIG. 40 shows how the fundus 16 and cardia 14 is located in a positionbelow the diaphragm 18 after having been pushed through the hiatalopening 18 a by the instrument 200.

FIG. 41 shows a subsequent step of the method. After the fundus 16 andcardia 14 has been pushed into its correct position below the diaphragm18, the wall of the fundus 16 a is affixed to the lower part of theoesophagus 24. This is carried out by using a member 209 in the proximalpart 205 of the instrument 200 which is capable of providing sutures orstaples 210. The fixation hinders the movement of the cardia 14 and thefundus 16 to a position above the diaphragm 18.

Other methods according to the invention are briefly described below.

A method of treating reflux disease of a patient comprises the step ofimplanting a reflux disease treatment system according to the inventioninto the patient's body.

A method of using the system for treating reflux disease according tothe invention comprises the step of regulating the devicepostoperatively to prevent reflux.

A method for surgically placing a movement restriction device accordingto the invention in a patient comprises the steps of cutting an openingin the abdominal wall of the patient, dissecting the area around thestomach, placing a movement restriction device attached to the stomachwall, and suturing the stomach wall.

A method of using a reflux disease treatment system, postoperativelycontrolled from outside the body, regulating the device, comprises thesteps of filling out a volume attached to a part of the stomach wall,and regulating the device from outside the patient's body to affect thereflux of the patient.

A method of using a movement restriction device comprises the steps offilling out a volume in a first part of the stomach wall by placing afirst part of the device, filling out a volume in a second part of thestomach wall by placing a second part of the device, and regulating thedevices from outside the patient's body to affect the reflux of thepatient.

A method of treating reflux disease in a patient comprises the steps ofinserting a needle or a tube like instrument into the abdomen of thepatient's body, using the needle or tube like instrument to fill thepatient's abdomen with gas thereby expanding the abdominal cavity,placing at least two laparoscopic trocars in the patient's body,inserting a camera through one of the laparoscopic trocars into thepatient's abdomen, inserting at least one dissecting tool through one ofsaid at least two laparoscopic trocars and dissecting an intendedplacement area of at least one portion of the stomach of the patient,placing a movement restriction device according to the invention on thestomach fundus wall, invaginating the device in the stomach fundus wall,suturing the stomach wall to itself to keep the device in place,suturing the fundus of the stomach towards the lower part of theoesophagus, and preventing the cardia to slide up through the diaphragminto the thorax. Using the method and device as described herein willprovide a treatment of Gastroesophageal Reflux Disease which is veryeffective and which does not suffer from complications such as damagingof tissue and undesired migration of non tissue into tissue.

The filling body of the device can be adapted to be pushed or pulledthrough a trocar for laparoscopic use, where the trocar has a diameterthat is smaller than the relaxed diameter of the body. The filling bodycan include an outer wall and a hollow gas filled inner part that allowthe body to pass through the trocar. Alternatively, the filling body caninclude an outer wall and a hollow fluid filled inner part that allowthe body to pass through the trocar. In this latter case, the fluid canbe a gel. The filling body can further include multiple parts that canbe inserted into the trocar, and that can then be put together into oneunitary piece inside the patient's body, allowing the filling body topass through the trocar. The filling body can include an outer wall anda hollow compressed inner part that is filled with a fluid or gel afterinsertion into the patient's body. The can further include an injectionport that can be used to fill the filling body with a fluid afterinsertion into the patient's body through the injection port.

The filling body of the device can be an elastic compressible material,allowing the filling body to pass through the trocar. The filling bodycan be made from a material that is softer than 25 shure, or even 15shure.

The filling body can also include an outer wall substantially taking theshape of a ball. The filling body can also include at least one holdingdevice adapted to be used for pushing or pulling the filling bodythrough a trocar for laparoscopic use. The holding device can be adaptedto hold a prolongation of the device that is adapted to be held by asurgical instrument. The holding device can also hold a tread or bandinserted through the holding device. The holding device can also be atleast partly placed inside the outer wall of the filling body. Thefilling body of the device can preferably has a size that is larger thanthe intestinal outlet from the stomach. to avoid ileus if the ball, as acomplication, should enter into the stomach. Preferably, the body has asmallest outer diameter between 30 mm and 40 mm or larger. Preferably,the body has a smallest outer circumference between 30 mm and 150 mm.

Preferred embodiments of a device for treating reflux disease, a systemcomprising a device for treating reflux disease, and a method accordingto the invention have been described. A person skilled in the artrealizes that these could be varied within the scope of the appendedclaims. Thus, although the different features have been described inspecific embodiments, it will be appreciated that they can be combinedin different configurations when applicable. For example, althoughhydraulic control has been described in association with the deviceconfiguration of FIG. 4 A-B, it can also be applied to the deviceconfigurations of FIGS. 2 A-B and 3A-B.

It is important that the implanted reflux treatment device is firmlykept in place in the stomach wall in which it is invaginated. To thisend, the reflux treatment device can be provided with one or morethrough holes adapted for receiving sutures or staples used for fixationof the invagination. Such an embodiment is shown in FIG. 42, where thereflux treatment device 10 is provided with a row of holes 10 i providedon a protruding flange-like protrusion on the reflux treatment device.In this embodiment, the row of holes extend along the longitudinal axisof the reflux treatment device.

FIG. 43 illustrates how sutures 314 are provided so that they runthrough the stomach wall 12 a and through the holes 10 i. In this way,the reflux treatment device is fixed in place in the pouch created fromthe stomach wall and will thus be prevented from sliding.

Although a plurality of holes is illustrated in the FIG. 42, it will beappreciated that one single hole is sufficient to obtain improvedfixation of the reflux treatment device 10.

FIG. 44 illustrates a reflux treatment device provided with an inletport 10 h. The reflux treatment device is invaginated in the stomachwall and the inlet port 10 h is available for connection to a tube orthe like from the abdominal area of the patient.

FIG. 45 illustrates an invaginated reflux treatment device wherein,instead of an inlet port, a fixed tube 10 g extends into the abdominalarea of the patient.

FIG. 46 is a figure similar to FIG. 44 but also illustrating tunnelingof a connection tube 10 g in the stomach wall between the inlet port 10h and the reflux treatment device 10.

It has been shown that the shape of the reflux treatment device can takemany different forms. It will be appreciated that also the material ofthe reflux treatment device can vary. It is preferred that the refluxtreatment device is provided with a coating, such as a Parylene,polytetrafluorocthylene (PTFE), or polyurethane coating, or acombination of such coatings, i.e., a multi-layer coating. This coatingor multi-layer coating improves the properties of the reflux treatmentdevice, such as its resistance to wear.

In one embodiment, the reflux treatment device comprises an inflatabledevice expandable to an expanded state. In this case, the inflatabledevice is provided with an inlet port for a fluid and is adapted to beconnected to a gastroscopic instrument. This embodiment will now bedescribed in detail with reference to FIGS. 47a -47 d.

An inflatable reflux treatment device in its non-expanded state is shownin FIG. 47a . It is essentially a balloon-like, deflated device 10having an inlet port 10 h. In this state, the inflatable device has adiameter of a few millimeters at the most, allowing it to be insertedinto the stomach through the esophagus of the patient by means of agastroscopic, tube-like instrument 600, depicted in FIG. 47h . Theinstrument comprises an outer sleeve 600 a and an inner sleeve 600 bwhich can be displaced longitudinally relatively to the outer sleeve.The inner sleeve is provided with a cutter in the form of a cutting edge615 at the distal end thereof. This cutting edge can be used for cuttinga hole in the stomach wall, as will be explained in detail in thefollowing.

When the instrument reaches a stomach wall, see FIG. 47c , the innersleeve is brought forward from its position in the outer sleeve and intocontact with the stomach wall 12 a. The cutting edge 615 of the innersleeve then cuts a hole in the stomach wall so as to allow subsequentinsertion of the reflux treatment device 10 into and through this hole,see FIG. 47d . In order to push the reflux treatment device through thehole, a piston 602 may be provided in the instrument. Thus, theinstrument further comprises a piston 602 adapted for pushing a deflatedreflux treatment device 10 out from a position in the inner sleeve, thisposition being shown in FIG. 47b , to a position outside of the innersleeve, this being shown in FIG. 47 d.

In order to protect the deflated reflux treatment device 10 from thecutting edge 615 of the inner sleeve, a further protective sleeve (notshown) can be provided around the reflux treatment device.

An intraluminar method of invaginating a reflux treatment device 10 onthe outside of the stomach wall 12 a will now be described withreference to FIGS. 48a-i . Initially, an instrument 600, preferably agastroscopic instrument, is inserted into the mouth of the patient, seeFIG. 48a . The instrument comprises an injection device 601, 602 forinjecting either fluid or a device into the stomach of the patient. Theinstrument 600 further comprises a control unit 606 adapted forcontrolling the operation of the instrument. To this end, the controlunit 606 comprises one or more steering devices, in the embodiment shownin the figure in the form of two joysticks 603 and two control buttons604. A display 605 is provided for displaying the image provided by acamera (not shown) arranged at the outer end of the elongated member607, see FIGS. 48e-i . The camera may be assisted by a light source (notshown).

The instrument is further inserted into the esophagus and into thestomach of the patient, see FIG. 48b . By means of the instrument 600, ahole 12 b is created in the wall of the stomach 12. To this end, theinstrument is provided with one or more cutters 615 at the distal endthereof, for example in the way described above with reference to FIGS.47a-d . These cutters can of course be designed in different ways, suchas a toothed drum cutter rotating about the center axis of the tube-likeinstrument. The instrument 600 is hollow providing a space for thereflux treatment device 10 in its deflated state.

After cutting a hole in the stomach wall, the distal end of theinstrument 600 is inserted into and through the hole 12 b so that itends up outside the stomach wall 12 a. This is shown in FIG. 48c ,showing a side view of the stomach 12, and FIG. 48d , which is asectional view through the stomach of FIG. 48c taken along the linesVd-Vd. The deflated reflux treatment device 10 is then inserted in theabdominal area.

The instrument 600 is adapted to create a “pocket” or “pouch” on theoutside of the stomach 12 around the hole 12 b in the stomach wall. Suchan instrument and the method of providing the pouch will now bedescribed.

FIGS. 48e-i show a gastroscopic or laparoscopic instrument forinvaginating a reflux treatment device 10 in the stomach wall 12 a ofthe patient by creating a pouch of stomach wall 12 a material in whichthe reflux treatment device is placed. The instrument, generallydesignated 600, and which may comprise the features described above withreference to FIGS. 47a-d , comprises an elongated member 607 having aproximal end and a distal end, the elongated member 607 having adiameter less than that of the patient's esophagus and being flexiblesuch as to allow introduction of the flexible elongated member 607 withits distal end first through the patient's throat, esophagus and intothe stomach 12 to the stomach wall 12 a.

The stomach penetration device or cutter 615 is provided on theelongated member 607 at the distal en thereof for penetrating thestomach wall 12 a so as to create a hole in the stomach wall 12 a, toallow introduction of the elongated member 607 through the hole. Thestomach penetration device 615 could be adapted to be operable forretracting said stomach penetration device 615 after the stomach funduswall 12 a has been penetrated, for not further damaging tissue withinthe body. The instrument further comprises a special holding device 609provided on the elongated member 607 on the proximal side to thepenetration device 615.

The elongated member further comprises an expandable member 611 which isadapted to be expanded after the elongated member has penetrated thestomach wall 12 a and thereby assist in the creation of a cavity orpouch adapted to hold the reflux treatment device 610. The expandablemember 611 may comprise an inflatable circular balloon providedcircumferentially around the distal end portion of the flexibleelongated member 607.

The method steps when invaginating the reflux treatment device will nowbe described in detail. After the instrument 600 has been inserted intothe stomach 12, the stomach penetration device 615 is placed intocontact with the stomach wall 12 a, see FIG. 48e . The stomachpenetration device or cutter 615 is then brought to create the hole 12 bin the stomach wall, whereafter at least the expandable member 611 isbrought through the hole 12 b in the stomach wall. The special holdingdevice 609 is in this step brought to a holding state wherein it expandsradially so as to form an essentially circular abutment surface to thestomach wall 12 a, see FIG. 48f . In this way, the insertion of thestomach penetration device 615 and the expandable member 611 through thehole 12 a in the stomach wall is limited to the position shown in FIG.48 f.

The expandable member 611 is then expanded. In the case the expandablemember comprises a balloon or the like, air or other fluid is injectedinto it.

The part of the elongated member 607 comprising the expandable member611 is then retracted in the proximal direction, as indicated by thearrow in FIG. 48g , thereby pulling the stomach wall 612 into a basketlike structure created by the special holding device 609.

A suturing or stapling device 608 is further provided, either as adevice connected to the elongated member 607 or as a separateinstrument. The suturing or stapling member comprises a suturing orstapling end 613 which is adapted to close the cavity or pouch by meansof stomach to stomach sutures or staples 14.

In a further step, illustrated in FIG. 48h , an inflatable refluxtreatment device 10 is placed in its deflated state in the basket likestructure. The reflux treatment device 10 is then inflated to itsinflated or expanded state, see FIG. 48i . This inflation of the refluxtreatment device 10 can be accomplished by injecting a fluid or a gelinto the deflated reflux treatment device. It can also be accomplishedby injecting a material which is allowed to cure, thereby forming asolid device 10. Thus, the reflux treatment device 10 shown in FIGS. 48hand 48i can illustrate either a balloon-like device which issubsequently filled with fluid or gel or alternatively a material whichis simply injected into the basket like structure formed by the stomachwall 12 a.

The fluid which is used to fill the reflux treatment device 10 could beany suitable fluid suitable to fill the inflatable device 10, such as asalt solution. In another embodiment, when this fluid is a fluid whichis adapted to be transformed into solid state, the fluid could be liquidpolyurethane.

In order to minimize or entirely eliminate leakage, the fluid isiso-tonic, i.e., it has the same osmolarity as human body fluids.Another way of preventing diffusion is to provide a fluid whichcomprises large molecules, such as iodine molecules.

The stomach-to-stomach sutures or staples are preferably provided withfixation portions exhibiting a structure, such as a net like structure,adapted to be in contact with the stomach wall to promote growth in ofhuman tissue to secure the long term placement of the reflux treatmentdevice attached to the stomach wall.

After the inflatable device 10 has been inflated, partly or fully, theinlet port 10 b (not shown in FIGS. 48h and 48i ) of the refluxtreatment device 10, is sealed and the instrument 600 is retracted fromthe hole 12 b, which is subsequently closed in some suitable way, suchas by means of the instrument 600. The instrument is then removed fromthe stomach 600 and the inflatable device 10 in its inflated or expandedstate is invaginated by a stomach wall portion of the patient on theoutside of the stomach wall. During one or more of the above describedsteps, the stomach may be inflated with gas, preferably by means of thegastroscopic instrument.

The reflux treatment device 10 described above with reference to FIGS.48a-i has been described as an inflatable reflux treatment device. Itwill be appreciated that is also can be an elastic reflux treatmentdevice with an elasticity allowing compression so as to be inserted intoa gastroscopic instrument and which expands to an expanded state afterleaving the instrument.

The apparatus for treating reflux can have the additional functionalityof treating obesity. In such an embodiment, the reflux treatment devicemay be a volume filling device that fills a volume of the stomach andthereby creating satiety. An embodiment having this function is shown inFIG. 49, wherein a combined reflux treatment device and obesitytreatment device 310 is invaginated in the stomach wall close to and atleast partially above the patient's cardia 14 when the patient is in astanding position and is fixed to a position above the cardia area 14 cby a fixation, such as sutures or staples 22. For example a direct orindirect fixation to the diaphragm muscle or associated muscles may beprovided. As an alternative a direct or indirect fixation to theesophagus above and close to the angle of His can be provided. In thisalternative embodiment, the combined device 310 rests in a positionagainst stomach wall of the fundus when implanted and which also fills avolume above the cardia area 14 c between the cardia and the diaphragmmuscle so that the cardia is prevented from slipping up into the thoraxcavity, whereby reflux disease is prevented.

Such a combined device 310 may be used for keeping electronics and/or anenergy source and/or hydraulic fluid. Hydraulic fluid from that devicemay be distributed to several smaller inflatable device areas to varythe stretching area from time to time avoiding any possible morepermanent stretching effect of the stomach wall. Even mechanicallyseveral stretching areas may be used.

Combination Reflux Treatment Device—Stretching Device

In an alternative embodiment, which is shown in FIG. 50, the volume ofan inflatable reflux treatment device 310 may be in fluid connectionwith one or more preferably smaller inflatable devices or chambers 10 b.These chambers are adapted to communicate with fluid or air being movedbetween the chambers.

Thus, the large chamber 310 is adapted to, with its main volume to be areflux treatment device for reducing the size of the food cavity and fortreating reflux disease and the one or several small chambers areadapted to function as the inflatable devices to treat obesity, whereinthe main chamber is adapted to communicate with fluid or air to thesmall chambers causing a stretching effect in the stomach wall therebyfurther treating obesity.

FIG. 51 show an embodiment with a combination of a volume filling deviceinvaginated in the central or lower portion of the stomach and astretching device invaginated in the upper portion or fundus of thepatient's stomach. These two devices serve to treat obesity.

The volume filling device 399 fills a volume of the stomach creatingsatiety. The stretching device stretches the wall of the stomach. Thisstretches the tissue setting off a endogenous signaling that createssatiety. This mimics the stretching effect of filling the stomach withfood. Thus, in FIG. 51 there is shown an adjustable volume fillingdevice 399, which is invaginated in the stomach wall of a patient'sstomach 312. Additionally, an adjustable stretching device 350 with thepreviously described function is invaginated in the stomach fundus wallof the patient. It is preferred that the volume filling device 399 issubstantially larger than the stretching device 350.

The volume filling device 399 and the stretching device 350 can beadapted to treat reflux. In one embodiment, the volume filling deviceand the stretching device are positioned to prevent the cardia 14 fromslipping upwards trough the opening of the hernia 18 a to a positionabove the diaphragm 18.

The volume filling device 399 and the stretching device 350 are in fluidcommunication with each other via a first fluid tube 352, in which apump 354 is provided. The pump 354 is under the control from an energytransforming device 330, which is adapted to supply the pump 350 withenergy via a power supply line 356. The energy transforming device 330is also connected to a sensor 319 provided in the esophagus of thepatient so that food intake can be detected.

The reflux treatment device 10 and the stretching device 350 are also influid communication with each other via a second fluid tube 358, whichpreferably has a smaller cross-sectional area than the first fluid tube352.

The operation of this arrangement is as follows. The volume fillingdevice 399 functions as in the above described embodiments, i.e., itreduces the size of the food cavity of the patient's stomach 12.Additionally, when the stretching device 350 is enlarged by pumpingfluid from the volume filling device 10 and to the stretching device 350by means of the pump 354, the stomach fundus wall is stretched, creatinga feeling of satiety for the patient. Thus, for example when food intakeis detected by means of the sensor 319, fluid is automatically pumpedinto the stretching device 350 to increase the feeling of satiety andthereby limit the food intake.

When fluid has been injected into the stretching device 350, theinternal pressure therein is higher than the internal pressure in thereflux treatment device 399. This difference in pressure will create aflow of fluid in the second, preferably narrower tube 358 from thestretching device 350 to the reflux treatment device 399. The flow ratewill be determined by among other things the difference in pressure andthe cross-sectional area of the second tube 358. It is preferred thatthe second tube is so dimensioned, that the pressures in the volumefiling device 399 and the stretching device 350 will return toequilibrium after 3 hours after fluid has been injected into thestretching device 350 to create the feeling of satiety.

In this embodiment, the function of the second tube 358 is to allowfluid to return from the stretching device 350 to the volume fillingdevice 399. It will be appreciated that this function also can beperformed by the pump 354 in the first tube 352 and that the second tube358 then can be omitted.

Method for Placing an Reflux Treatment Device on the Inside of theStomach Wall:

In the following a method and an instrument for placing a refluxtreatment device on the inside of the stomach wall will be described.

The invagination instrument described in FIG. 52a-h generally designated630, comprises an elongated tube member 632 similar to the elongatedmember 607 described above with reference to FIGS. 48a-i . Thus, it canbe connected to a control unit 606, see FIG. 48a . The invaginationinstrument 630 further comprises a perforated suction portion 634, whichpreferably is elongated. The suction portion 634 exhibits a plurality ofsmall holes 636, into which air will be sucked by providing suction inthe tube member 632. This suction effect will be used to create a“pocket” or “pouch” in a part of a stomach wall, generally designated 12a.

In other words, when the tip of the suction portion 634 is pressedagainst the stomach wall 12 a, see FIG. 52a , a small recess will beformed therein. When the suction portion 634 is further pressed againstthe stomach wall 12 a, see FIG. 52b , a larger recess will be formed.The part of the stomach wall 12 a that forms the recess will, due to thesuction effect, adhere to the suction portion 634 of the invaginationinstrument 630. As the suction portion 634 is further pressed into thestomach wall 12 a, see FIG. 52c , a deeper recess will be formed untilthe entire suction portion 634 is embedded in the recess, see FIG. 52 d.

The rim of the recess will at this stage be fixated by means of fixationelements 638 and the suction portion be removed from the instrument, seeFIG. 52e . A compressed elastic reflux treatment device 10 willsubsequently be inserted into the recess, see FIG. 52f , for example inthe way described above with reference to FIG. 47d . This compressedreflux treatment device is then expanded to its final shape, see FIG.52g , where after the pouch is sealed by suturing or stapling by meansof the fixations elements, see FIG. 52 h.

All the alternatives described above with reference to FIGS. 1-51 arealso applicable to the embodiment described with reference to FIGS.52a-l , i.e., to the embodiment where the reflux treatment device isinvaginated on the inside of the stomach wall.

FIGS. 53 a-c show an instrument for creating an invagiation of the wallof the stomach that can either be placed on the outside of the wall ofthe stomach or on the inside of the wall of the stomach depending if thereflux treatment device is place on the inside or the outside of thewall. The instrument uses vacuum to such a portion of the wall of thestomach into the cup of the instrument.

It has been described how the reflux treatment device 10 is invaginatedin the stomach wall by means of a gastroscopic instrument. Thegastroscopic instrument can be used for either placing the refluxtreatment device on the outside of the wall of the stomach as shown inFIG. 1A or on the inside of the stomach as shown in FIG. 2A. In thelatter case, the instruments will be used to make an incision in thewall of the stomach from the inside of the stomach.

It will be appreciated that abdominal operation methods can be used aswell. Such methods will now be described in with reference to FIGS.54-55. In FIG. 54 it is shown how the stomach is accessed by creating anincision 380 in the abdomen of the patient. In FIG. 55 it is shown howan instrument 381 is inserted into the abdomen of the patient. Any ofthe instruments and methods described can be selected an adapted forthis purpose. Thus, for example, the reflux treatment device can beplaced on the outside of the stomach as shown in FIG. 1A or on theinside as shown in FIG. 2A. In the later case an incision is made in thewall of the stomach.

It is important that the implanted reflux treatment device is firmlykept in place in the stomach wall in which it is invaginated. To thisend, the reflux treatment device can be provided with one or morethrough holes adapted for receiving sutures or staples used for fixationof the invagination. Such an embodiment is shown in FIG. 42, where thereflux treatment device 10 is provided with a row of holes 10 i providedon a protruding flange-like protrusion on the reflux treatment device.In this embodiment, the row of holes extend along the longitudinal axisof the reflux treatment device.

FIG. 43 illustrates how sutures 314 are provided so that they runthrough the stomach wall 12 a and through the holes 10 i. In this way,the reflux treatment device is fixed in place in the pouch created fromthe stomach wall and will thus be prevented from sliding.

Although a plurality of holes is illustrated in the FIG. 42, it will beappreciated that one single hole is sufficient to obtain improvedfixation of the reflux treatment device 10.

FIG. 44 illustrates a reflux treatment device provided with an inletport 10 h. The reflux treatment device is invaginated in the stomachwall and the inlet port 10 h is available for connection to a tube orthe like from the abdominal area of the patient.

FIG. 45 illustrates an invaginated reflux treatment device wherein,instead of an inlet port, a fixed tube 10 g extends into the abdominalarea of the patient.

FIG. 46 is a figure similar to FIG. 44 but also illustrating tunnelingof a connection tube 10 g in the stomach wall between the inlet port 10h and the reflux treatment device 10.

It has been shown that the shape of the reflux treatment device can takemany different forms. It will be appreciated that also the material ofthe reflux treatment device can vary. It is preferred that the refluxtreatment device is provided with a coating, such as a Parylene,polytetrafluoroethylene (PTFE), or polyurethane coating, or acombination of such coatings, i.e., a multi-layer coating. This coatingor multi-layer coating improves the properties of the reflux treatmentdevice, such as its resistance to wear.

In one embodiment, the reflux treatment device comprises an inflatabledevice expandable to an expanded state. In this case, the inflatabledevice is provided with an inlet port for a fluid and is adapted to beconnected to a gastroscopic instrument. This embodiment will now bedescribed in detail with reference to FIGS. 47a -47 d.

An inflatable reflux treatment device in its non-expanded state is shownin FIG. 47a . It is essentially a balloon-like, deflated device 10having an inlet port 10 h. In this state, the inflatable device has adiameter of a few millimeters at the most, allowing it to be insertedinto the stomach through the esophagus of the patient by means of agastroscopic, tube-like instrument 600, depicted in FIG. 47b . Theinstrument comprises an outer sleeve 600 a and an inner sleeve 600 bwhich can be displaced longitudinally relatively to the outer sleeve.The inner sleeve is provided with a cutter in the form of a cutting edge615 at the distal end thereof. This cutting edge can be used for cuttinga hole in the stomach wall, as will be explained in detail in thefollowing.

When the instrument reaches a stomach wall, see FIG. 47c , the innersleeve is brought forward from its position in the outer sleeve and intocontact with the stomach wall 12 a. The cutting edge 615 of the innersleeve then cuts a hole in the stomach wall so as to allow subsequentinsertion of the reflux treatment device 10 into and through this hole,see FIG. 47d . In order to push the reflux treatment device through thehole, a piston 602 may be provided in the instrument. Thus, theinstrument further comprises a piston 602 adapted for pushing a deflatedreflux treatment device 10 out from a position in the inner sleeve, thisposition being shown in FIG. 47b , to a position outside of the innersleeve, this being shown in FIG. 47 d.

In order to protect the deflated reflux treatment device 10 from thecutting edge 615 of the inner sleeve, a further protective sleeve (notshown) can be provided around the reflux treatment device.

An intraluminar method of invaginating a reflux treatment device 10 onthe outside of the stomach wall 12 a will now be described withreference to FIGS. 48a-i . Initially, an instrument 600, preferably agastroscopic instrument, is inserted into the mouth of the patient, seeFIG. 48a . The instrument comprises an injection device 601, 602 forinjecting either fluid or a device into the stomach of the patient. Theinstrument 600 further comprises a control unit 606 adapted forcontrolling the operation of the instrument. To this end, the controlunit 606 comprises one or more steering devices, in the embodiment shownin the figure in the form of two joysticks 603 and two control buttons604. A display 605 is provided for displaying the image provided by acamera (not shown) arranged at the outer end of the elongated member607, see FIGS. 48e-i . The camera may be assisted by a light source (notshown).

The instrument is further inserted into the esophagus and into thestomach of the patient, see FIG. 48b . By means of the instrument 600, ahole 12 b is created in the wall of the stomach 12. To this end, theinstrument is provided with one or more cutters 615 at the distal endthereof, for example in the way described above with reference to FIGS.47a-d . These cutters can of course be designed in different ways, suchas a toothed drum cutter rotating about the center axis of the tube-likeinstrument. The instrument 600 is hollow providing a space for thereflux treatment device 10 in its deflated state.

After cutting a hole in the stomach wall, the distal end of theinstrument 600 is inserted into and through the hole 12 b so that itends up outside the stomach wall 12 a. This is shown in FIG. 48c ,showing a side view of the stomach 12, and FIG. 48d , which is asectional view through the stomach of FIG. 48c taken along the linesVd-Vd. The deflated reflux treatment device 10 is then inserted in theabdominal area.

The instrument 600 is adapted to create a “pocket” or “pouch” on theoutside of the stomach 12 around the hole 12 b in the stomach wall. Suchan instrument and the method of providing the pouch will now bedescribed.

FIGS. 48o-i show a gastroscopic or laparoscopic instrument forinvaginating a reflux treatment device 10 in the stomach wall 12 a ofthe patient by creating a pouch of stomach wall 12 a material in whichthe reflux treatment device is placed. The instrument, generallydesignated 600, and which may comprise the features described above withreference to FIGS. 47a-d , comprises an elongated member 607 having aproximal end and a distal end, the elongated member 607 having adiameter less than that of the patient's esophagus and being flexiblesuch as to allow introduction of the flexible elongated member 607 withits distal end first through the patient's throat, esophagus and intothe stomach 12 to the stomach wall 12 a.

The stomach penetration device or cutter 615 is provided on theelongated member 607 at the distal en thereof for penetrating thestomach wall 12 a so as to create a hole in the stomach wall 12 a, toallow introduction of the elongated member 607 through the hole. Thestomach penetration device 615 could be adapted to be operable forretracting said stomach penetration device 615 after the stomach funduswall 12 a has been penetrated, for not further damaging tissue withinthe body. The instrument further comprises a special holding device 609provided on the elongated member 607 on the proximal side to thepenetration device 615.

The elongated member further comprises an expandable member 611 which isadapted to be expanded after the elongated member has penetrated thestomach wall 12 a and thereby assist in the creation of a cavity orpouch adapted to hold the reflux treatment device 610. The expandablemember 611 may comprise an inflatable circular balloon providedcircumferentially around the distal end portion of the flexibleelongated member 607.

The method steps when invaginating the reflux treatment device will nowbe described in detail. After the instrument 600 has been inserted intothe stomach 12, the stomach penetration device 615 is placed intocontact with the stomach wall 12 a, see FIG. 48e . The stomachpenetration device or cutter 615 is then brought to create the hole 12 bin the stomach wall, whereafter at least the expandable member 611 isbrought through the hole 12 b in the stomach wall. The special holdingdevice 609 is in this step brought to a holding state wherein it expandsradially so as to form an essentially circular abutment surface to thestomach wall 12 a, see FIG. 48f . In this way, the insertion of thestomach penetration device 615 and the expandable member 611 through thehole 12 a in the stomach wall is limited to the position shown in FIG.48 f.

The expandable member 611 is then expanded. In the case the expandablemember comprises a balloon or the like, air or other fluid is injectedinto it.

The part of the elongated member 607 comprising the expandable member611 is then retracted in the proximal direction, as indicated by thearrow in FIG. 48g , thereby pulling the stomach wall 612 into a basketlike structure created by the special holding device 609.

A suturing or stapling device 608 is further provided, either as adevice connected to the elongated member 607 or as a separateinstrument. The suturing or stapling member comprises a suturing orstapling end 613 which is adapted to close the cavity or pouch by meansof stomach to stomach sutures or staples 14.

In a further step, illustrated in FIG. 48h , an inflatable refluxtreatment device 10 is placed in its deflated state in the basket likestructure. The reflux treatment device 10 is then inflated to itsinflated or expanded state, see FIG. 48i . This inflation of the refluxtreatment device 10 can be accomplished by injecting a fluid or a gelinto the deflated reflux treatment device. It can also be accomplishedby injecting a material which is allowed to cure, thereby forming asolid device 10. Thus, the reflux treatment device 10 shown in FIGS. 48hand 48i can illustrate either a balloon-like device which issubsequently filled with fluid or gel or alternatively a material whichis simply injected into the basket like structure formed by the stomachwall 12 a.

The fluid which is used to fill the reflux treatment device 10 could beany suitable fluid suitable to fill the inflatable device 10, such as asalt solution. In another embodiment, when this fluid is a fluid whichis adapted to be transformed into solid state, the fluid could be liquidpolyurethane.

In order to minimize or entirely eliminate leakage, the fluid isiso-tonic, i.e., it has the same osmolarity as human body fluids.Another way of preventing diffusion is to provide a fluid whichcomprises large molecules, such as iodine molecules.

The stomach-to-stomach sutures or staples are preferably provided withfixation portions exhibiting a structure, such as a net like structure,adapted to be in contact with the stomach wall to promote growth in ofhuman tissue to secure the long term placement of the reflux treatmentdevice attached to the stomach wall.

After the inflatable device 10 has been inflated, partly or fully, theinlet port 10 b (not shown in FIGS. 48h and 48i ) of the refluxtreatment device 10, is sealed and the instrument 600 is retracted fromthe hole 12 b, which is subsequently closed in some suitable way, suchas by means of the instrument 600. The instrument is then removed fromthe stomach 600 and the inflatable device 10 in its inflated or expandedstate is invaginated by a stomach wall portion of the patient on theoutside of the stomach wall. During one or more of the above describedsteps, the stomach may be inflated with gas, preferably by means of thegastroscopic instrument.

The reflux treatment device 10 described above with reference to FIGS.48a-i has been described as an inflatable reflux treatment device. Itwill be appreciated that is also can be an elastic reflux treatmentdevice with an elasticity allowing compression so as to be inserted intoa gastroscopic instrument and which expands to an expanded state afterleaving the instrument.

The apparatus for treating reflux can have the additional functionalityof treating obesity. In such an embodiment, the reflux treatment devicemay be a volume filling device that fills a volume of the stomach andthereby creating satiety. An embodiment having this function is shown inFIG. 49, wherein a combined reflux treatment device and obesitytreatment device 310 is invaginated in the stomach wall close to and atleast partially above the patient's cardia 14 when the patient is in astanding position and is fixed to a position above the cardia area 14 cby a fixation, such as sutures or staples 22. For example a direct orindirect fixation to the diaphragm muscle or associated muscles may beprovided. As an alternative a direct or indirect fixation to theesophagus above and close to the angle of His can be provided. In thisalternative embodiment, the combined device 310 rests in a positionagainst stomach wall of the fundus when implanted and which also fills avolume above the cardia area 14 c between the cardia and the diaphragmmuscle so that the cardia is prevented from slipping up into the thoraxcavity, whereby reflux disease is prevented.

Such a combined device 310 may be used for keeping electronics and/or anenergy source and/or hydraulic fluid. Hydraulic fluid from that devicemay be distributed to several smaller inflatable device areas to varythe stretching area from time to time avoiding any possible morepermanent stretching effect of the stomach wall. Even mechanicallyseveral stretching areas may be used.

Combination Reflux Treatment Device—Stretching Device

In an alternative embodiment, which is shown in FIG. 50, the volume ofan inflatable reflux treatment device 310 may be in fluid connectionwith one or more preferably smaller inflatable devices or chambers 10 b.These chambers are adapted to communicate with fluid or air being movedbetween the chambers.

Thus, the large chamber 310 is adapted to, with its main volume to be areflux treatment device for reducing the size of the food cavity and fortreating reflux disease and the one or several small chambers areadapted to function as the inflatable devices to treat obesity, whereinthe main chamber is adapted to communicate with fluid or air to thesmall chambers causing a stretching effect in the stomach wall therebyfurther treating obesity.

FIG. 51 show an embodiment with a combination of a volume filling deviceinvaginated in the central or lower portion of the stomach and astretching device invaginated in the upper portion or fundus of thepatient's stomach. These two devices serve to treat obesity.

The volume filling device 399 fills a volume of the stomach creatingsatiety. The stretching device stretches the wall of the stomach. Thisstretches the tissue setting off a endogenous signaling that createssatiety. This mimics the stretching effect of filling the stomach withfood. Thus, in FIG. 51 there is shown an adjustable volume fillingdevice 399, which is invaginated in the stomach wall of a patient'sstomach 312. Additionally, an adjustable stretching device 350 with thepreviously described function is invaginated in the stomach fundus wallof the patient. It is preferred that the volume filling device 399 issubstantially larger than the stretching device 350.

The volume filling device 399 and the stretching device 350 can beadapted to treat reflux. In one embodiment, the volume filling deviceand the stretching device are positioned to prevent the cardia 14 fromslipping upwards trough the opening of the hernia 18 a to a positionabove the diaphragm 18.

The volume filling device 399 and the stretching device 350 are in fluidcommunication with each other via a first fluid tube 352, in which apump 354 is provided. The pump 354 is under the control from an energytransforming device 330, which is adapted to supply the pump 350 withenergy via a power supply line 356. The energy transforming device 330is also connected to a sensor 319 provided in the esophagus of thepatient so that food intake can be detected.

The reflux treatment device 10 and the stretching device 350 are also influid communication with each other via a second fluid tube 358, whichpreferably has a smaller cross-sectional area than the first fluid tube352.

The operation of this arrangement is as follows. The volume fillingdevice 399 functions as in the above described embodiments, i.e., itreduces the size of the food cavity of the patient's stomach 12.Additionally, when the stretching device 350 is enlarged by pumpingfluid from the volume filling device 10 and to the stretching device 350by means of the pump 354, the stomach fundus wall is stretched, creatinga feeling of satiety for the patient. Thus, for example when food intakeis detected by means of the sensor 319, fluid is automatically pumpedinto the stretching device 350 to increase the feeling of satiety andthereby limit the food intake.

When fluid has been injected into the stretching device 350, theinternal pressure therein is higher than the internal pressure in thereflux treatment device 399. This difference in pressure will create aflow of fluid in the second, preferably narrower tube 358 from thestretching device 350 to the reflux treatment device 399. The flow ratewill be determined by among other things the difference in pressure andthe cross-sectional area of the second tube 358. It is preferred thatthe second tube is so dimensioned, that the pressures in the volumefiling device 399 and the stretching device 350 will return toequilibrium after 3 hours after fluid has been injected into thestretching device 350 to create the feeling of satiety.

In this embodiment, the function of the second tube 358 is to allowfluid to return from the stretching device 350 to the volume fillingdevice 399. It will be appreciated that this function also can beperformed by the pump 354 in the first tube 352 and that the second tube358 then can be omitted.

Method for Placing an Reflux Treatment Device on the Inside of theStomach Wall:

In the following a method and an instrument for placing a refluxtreatment device on the inside of the stomach wall will be described.

The invagination instrument described in FIG. 52a -1 generallydesignated 630, comprises an elongated tube member 632 similar to theelongated member 607 described above with reference to FIGS. 48a-i .Thus, it can be connected to a control unit 606, see FIG. 48a . Theinvagination instrument 630 further comprises a perforated suctionportion 634, which preferably is elongated. The suction portion 634exhibits a plurality of small holes 636, into which air will be suckedby providing suction in the tube member 632. This suction effect will beused to create a “pocket” or “pouch” in a part of a stomach wall,generally designated 12 a.

In other words, when the tip of the suction portion 634 is pressedagainst the stomach wall 12 a, see FIG. 52a , a small recess will beformed therein. When the suction portion 634 is further pressed againstthe stomach wall 12 a, see FIG. 52b , a larger recess will be formed.The part of the stomach wall 12 a that forms the recess will, due to thesuction effect, adhere to the suction portion 634 of the invaginationinstrument 630. As the suction portion 634 is further pressed into thestomach wall 12 a, see FIG. 52c , a deeper recess will be formed untilthe entire suction portion 634 is embedded in the recess, see FIG. 18 d.

The rim of the recess will at this stage be fixated by means of fixationelements 638 and the suction portion be removed from the instrument, seeFIG. 52e . A compressed elastic reflux treatment device 10 willsubsequently be inserted into the recess, see FIG. 52f , for example inthe way described above with reference to FIG. 47d . This compressedreflux treatment device is then expanded to its final shape, see FIG.52h , where after the pouch is scaled by suturing or stapling by meansof the fixations elements, see FIG. 52 i.

All the alternatives described above with reference to FIGS. 1-51 arealso applicable to the embodiment described with reference to FIGS.52a-l , i.e., to the embodiment where the reflux treatment device isinvaginated on the inside of the stomach wall.

FIGS. 53 a-c show an instrument for creating an invagiation of the wallof the stomach that can either be placed on the outside of the wall ofthe stomach or on the inside of the wall of the stomach depending if thereflux treatment device is place on the inside or the outside of thewall. The instrument uses vacuum to such a portion of the wall of thestomach into the cup of the instrument.

It has been described how the reflux treatment device 10 is invaginatedin the stomach wall by means of a gastroscopic instrument. Thegastroscopic instrument can be used for either placing the refluxtreatment device on the outside of the wall of the stomach as shown inFIG. 1A or on the inside of the stomach as shown in FIG. 2A. In thelatter case, the instruments will be used to make an incision in thewall of the stomach from the inside of the stomach.

It will be appreciated that abdominal operation methods can be used aswell. Such methods will now be described in with reference to FIGS.54-55. In FIG. 54 it is shown how the stomach is accessed by creating anincision 380 in the abdomen of the patient. In FIG. 55 it is shown howan instrument 381 is inserted into the abdomen of the patient. Any ofthe instruments and methods described can be selected an adapted forthis purpose. Thus, for example, the reflux treatment device can beplaced on the outside of the stomach as shown in FIG. 1A or on theinside as shown in FIG. 2A. In the later case an incision is made in thewall of the stomach.

1.-56. (canceled)
 57. A biocompatible implant for a method of treating areflux disease in a patient by preventing the cardia sphincter fromsliding through the patient's diaphragm hiatus opening into thepatient's thorax, so as to maintain a pressure support from thepatient's abdomen that supports the patient's cardia sphincter, saidbiocompatible implant has a rigid shape, a circumference of at least 15mm and is configured to: be introduced into the patient's abdomenthrough a trocar, be fully invaginatable in the patient's fundus wall,and function as an implantable movement restricting device preventingthe cardia sphincter from sliding through the patient's diaphragm, whenimplanted.
 58. The biocompatible implant according to claim 57, whereinthe rigid shape is substantially spherical.
 59. The biocompatibleimplant according to claim 57, wherein an outer wall of thebiocompatible implant is rigid enough to maintain non-deformed whensubject to forces created by stomach movements.
 60. The biocompatibleimplant according to claim 57, wherein the biocompatible implant isnon-inflatable.
 61. The biocompatible implant according to claim 57,wherein the biocompatible implant includes a homogenous material. 62.The biocompatible implant according to claim 57, wherein thebiocompatible implant is solid.
 63. The biocompatible implant accordingto claim 57, wherein the biocompatible implant is destructible bystomach acid.
 64. The biocompatible implant according to claim 57,wherein the biocompatible implant comprises a sunken ridge adapted to beheld with a surgical tool.